Part 1. Overview Information

Key Dates

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of the Global Implementation Science for Equitable Cancer Control (GlobalISE Cancer Control) Funding Opportunity Announcement (FOA) is to build a consortium of implementation science centers in low- and middle-income countries (LMICs). This initiative will support implementation science research capacity-building activities, including research projects that identify, develop, and test innovative theory-based strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based cancer control interventions (e.g., programs, tools, policies, and guidelines) in LMICs. NCI will support several U54 Specialized Centers with transdisciplinary research teams meaningfully collaborating with key stakeholders (e.g., health systems, ministries of health, clinicians, and communities) that must include at least one PI or MPI from an LMIC-based institution. This initiative aims to foster LMIC-based implementation science programs to inform implementation of cancer control efforts in LMICs.

Key Definitions for this FOA:

Implementation Science: the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine health care and public health settings to improve our impact on population health. It seeks to understand the behavior of relevant individuals (e.g., clinicians, public health practitioners, administrators) and systems (e.g., healthcare systems, community-based organizations) as key drivers in the adoption, implementation, and sustainment of evidence-based interventions.

Low- and Middle-Income Countries (LMICs): LMICs are defined by the World Bank classification system according to Gross National Income per capita as "low-income," "lower-middle-income," and "upper-middle-income".

GlobalISE Cancer Control: Refers to the combined activities of the U54 Centers and the NCI to advance the science of implementation in cancer control in LMICs through innovative studies, structured mentoring, additional field capacity development, improved methods and measurement, and other consortium activities.

Clinical Trials: The NIH definition of a clinical trial stated in NOT-OD-15-015 applies to this FOA. A clinical trial is defined as 'research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes'.

Background

Global Cancer Burden: Nearly 20 million new cancer cases and almost 10 million cancer deaths occurred worldwide in 2020, and new cancer cases are projected to increase by 47% to 28.4 million in 2040. While overall cancer mortality has been decreasing in high income countries, about 60-70% of cancer deaths occur in low- and middle-income countries (LMICs), highlighting the global inequities in cancer control. According to the 2020 WHO Report on Cancer, progress in reducing premature deaths from cancer is significantly slower in low-income countries compared with high-income countries, which will exacerbate inequities over time.

Evidence-Based Cancer Control Interventions: Effective interventions across the cancer care continuum can prevent premature death from cancer. These include over 200 programs currently listed in NCI’s Evidence-Based Cancer Control Programs database. However, their application in LMICs at a broad scale has been inconsistent and incomplete, often because implementation can be complex and challenging. Evidence-based interventions developed and tested in high-income countries may require adaptation and use of novel strategies to be successfully implemented in LMICs, accounting for limited resources, different health systems, and diverse social and cultural contexts. Moreover, the COVID-19 pandemic has markedly disrupted fragile cancer control systems in LMICs, which were already in many cases susceptible to frequent disruption from economic, political, and natural causes. In the face of current and future disruptions, major implementation science opportunities exist for more equitable and resilient global cancer control.

The Role of Implementation Science: Implementation science is the discipline that provides us with guidance and tools for systematically and rigorously understanding how best to implement evidence-based interventions. Implementation science focuses on addressing the challenges of the underuse of effective interventions, tools, and programs to better prevent, diagnose, and treat cancer. The field offers methods and frameworks to evaluate multilevel factors and processes that influence implementation and develop and test strategies that can overcome barriers to the adoption, integration, and sustainability of effective cancer control interventions in a variety of settings.

Gaps in Global Implementation Science: In LMICs, there have been many context-specific efforts to implement cancer control interventions, often using incredibly innovative approaches to overcome enormous contextual challenges. However, those efforts are not necessarily being conducted nor captured in a systematic and rigorous way such that they can inform broader scale-up. In a systematic review of over 10,000 research articles published between 1998 and 2016 on a range of health interventions in LMICs not limited to cancer, only a small fraction captured information to inform implementation efforts, such as an understanding of contextual barriers and facilitators, affected implementers, adaptations made, or practice implications. Even fewer documented key implementation outcomes such as adoption, fidelity, feasibility, acceptability, penetration, and sustainability. This represents a missed opportunity to capture the large reservoir of accumulating knowledge regarding implementation that can inform ongoing and future efforts. It also underscores the need for dedicated training and capacity-building in implementation science in LMICs.

Opportunities to Advance Global Cancer Control: NCI has made significant investments in implementation science in cancer control across the cancer care continuum. However, there is limited evidence to guide the adoption, adaptation, integration, sustainability, and scale-up of effective cancer control interventions in LMIC settings. A focus on these efforts can improve equitable access to evidence-based cancer control programs and inform implementation in low-resource settings both domestically and globally to reduce cancer morbidity and mortality worldwide.

The goals of the Global Implementation Science for Equitable Cancer Control (GlobalISE Cancer Control) Funding Opportunity Announcement (FOA) are to build research capacity for implementation science in low- and middle-income countries (LMICs) and to support implementation science research projects that identify, develop, and test innovative theory-based strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based cancer control interventions in LMICs. To this end, applications must include at least one PI or MPI from an LMIC-based institution.

Research Objectives

This FOA supports efforts to conduct and build capacity for global implementation science for cancer control in LMICs through U54 research centers. Each Center will identify an overall scientific theme and specific goals. Potential theme areas for a Center to focus on include but are not limited to:

• Advancing understanding of intervention adaptation in the context of clinical and community settings;
• Developing and testing implementation strategies to efficiently bundle cancer control services (e.g., multiple cancer control intervention);
• Developing and testing implementation strategies to effectively integrate cancer control into primary care or other care settings;
• Developing and testing implementation strategies to decentralize cancer control services to community settings;
• Developing and testing strategies to enhance patient retention across the continuum of cancer care in fragmented systems;
• Advancing understanding around sustainment of evidence-based cancer control interventions;
• Advancing understanding around scaling up evidence-based cancer control interventions across systems and communities.

Required U54 Components

The Center and its components should be integrated and connected by one overarching theme. Center applicants must be from, or partner with, an LMIC-based institution. The proposed U54 Center must include all the required components listed below.

• Research Projects (required). At least two, but not exceeding three, well-defined research projects are required. Each project must address a question that advances scientific knowledge in cancer control implementation science in LMICs and at least one project must test an implementation strategy. The proposed projects must be well developed, rigorous, and supported by a strong rationale that is based on integrating the available relevant information from various sources (e.g., extant literature).
• Administrative and Engagement Core (required) will be responsible for the overall administration, coordination, and management of the Center. The Core will also be critical in fostering productive collaboration between researchers and key stakeholders in the LMIC setting (including practitioners and health system leaders) throughout all phases of the award. Partnership and dissemination activities may include the presentation of findings from research projects and pilot projects to translate findings into sustainable community and system-level changes at the local level and beyond. Core activities are expected to contribute to scientific advancements such as improved implementation of interventions based on local knowledge and strengthened practitioner-engaged research approaches.
• Research Capacity Building Core (required) will focus on activities to facilitate and enhance the professional development of early-career LMIC-based investigators to build a cadre of scholars who are well versed in conducting implementation science in LMICs. Further, this core will identify and incorporate into all the research and pilot projects the use of implementation science frameworks, designs, and contextual, process, and outcome measures, accounting for multiple socioecological levels, and if relevant, include details on the development and use of emerging and innovative technologies relevant to the research. Applicants are encouraged to develop innovative and sustainable models of mentoring, career development, and research training. Capacity-building programs may focus on the development of independent researchers, post-doctoral students, and graduate students, as well as implementation practitioners involved in research (e.g., community health workers, clinicians, and staff of health service delivery systems, regional governmental or non-governmental organizations, or other technical personnel). Each trainee must have a mentor, and trainees must devote at least 50% of full-time professional effort to the Center research project. The Research Capacity Building Component should support the salary and costs of candidates with outstanding potential, as well as other reasonable costs for career development and training activities.

Activities may include but are not limited to:

• Sharing education platforms to strengthen and develop expertise across research team members in participating institutions.
• Engaging trainees and early career investigators from the participating institutions in knowledge exchange on topics relevant to the Center research theme.
• Providing opportunities for obtaining relevant research experience and building expertise in implementation research.
• Developing and disseminating implementation science tools and methods to support the development of future studies.
• Grantsmanship Training and training to develop oral and written scientific communication capabilities.
• Professional development in grants administration to foster proficiency in the management of scientific and administrative aspects of the grant.
• Contributing to informing and disseminating common measures/data elements relevant to evidence-based cancer control programs where the study is taking place.

This FOA aims to encourage transdisciplinary teams of researchers, implementers, and other key stakeholders to develop and test implementation strategies that may be applicable across a diverse range of contexts and populations. Impactful implementation science typically involves and benefits from interdisciplinary collaboration from a variety of fields. Some of these fields include but are not limited to global health, anthropology, epidemiology, systems science, organizational and management theory, economics, individual and systems-level behavioral change, engineering, and marketing. Applicant teams should include investigators that provide the necessary expertise to complete the research aims.

The centers funded through this consortium will work together to share research methods and measures, train LMIC-based investigators in implementation science, and meaningfully collaborate with implementers across communities and health systems. Research projects should be designed to rigorously assess implementation outcomes (e.g., acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration, sustainability) of the strategies under study. Additionally, this FOA seeks to develop sustained research capacity for implementation research through training activities and structured mentoring programs within LMIC-based academic institutions, clinical, and community sites.

Information relevant to other specific Institutes/Centers

National Institute of Mental Health (NIMH)
The National Institute of Mental Health encourages the implementation science projects to integrate mental health services across the cancer care continuum, including during cancer prevention, detection, diagnosis, treatment, palliative care, and survivorship. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. All applications that propose clinical trials are encouraged to follow the NIMH’s experimental therapeutics approach to intervention development and testing (see NIMH Clinical Trials FOAs). It is recommended that investigators contact NIMH Scientific/Research staff before submitting applications to discuss the match to NIMH priorities.

Non-responsive Applications

Applications with the following attributes will be deemed non-responsive and will not be reviewed:

• Applications focused primarily on the development and testing of new interventions, including studies primarily focused on evaluating intervention efficacy.
• Applications lacking key personnel from LMICs with substantial involvement in the research activities. (Note: Applications must include at least one PI or MPI from an LMIC-based institution.)
• Applications proposing any clinical trials that include clinical development or testing of interventions for therapeutic or diagnostic or preventive purposes, or evaluation of intervention safety, efficacy, and clinical management.
• Applications proposing a self-standing institutional training/education/career development program (for example, activities towards a specific degree).
• Applications that propose projects that do not address cancer prevention or control.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 FOA.

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 Governments

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

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

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

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 full SAM and 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.

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

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

The use of the multiple PD/PI (MPI) administrative structure is strongly encouraged for this program. For institutions/organizations proposing a single PD/PI, the PD/PI will be required to have a primary academic appointment in an LMIC institution. Applications proposing MPIs will be required to include at least one PD/PI who has a primary academic appointment in an LMIC institution where the projects occur. Applications proposing MPIs can have a contact PI in either institution. Research projects must be conducted in the LMIC in which the single PD/PI or at least one PD/PI has a primary appointment. Multiple PD/PI(s) should have a documented history of collaboration relevant to the proposed program or clear rationale for a new collaboration to meet the strategic goals of the proposed Research Center.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Gila Neta, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

• Overall: required
• Administrative and Engagement Core: required
• Research Capacity Building Core: required
• Research Projects: 2 required, maximum 3 allowed

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire Center application.

Project Narrative: In the "Project Narrative", it is encouraged that the relevance of the Center’s research to public health should be stated in lay language.

Facilities and Other Resources: Include any information about available unique resources and/or special capabilities that may be relevant for collaborative studies. List all available resources pertinent to the research. Identify which partner is contributing which resources. Indicate which specific resources will be available to other partners in the U54 GlobalISE Cancer Control Consortium (e.g., training programs, access to populations or data for implementation studies). Include a summary of resources that will be available to support new scientific leaders in implementation science.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Biosketches: In addition to standard items, provide documentation for any previous collaborations with other designated PDs/PIs, including, as appropriate joint projects/publications, joint grants, participation in previous NIH and non-NIH initiatives etc.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:

Describe the overall goals of the proposed U54 Center, including the integration of the overall theme with the research projects and cores.

Research Strategy: The research strategy should provide an overview of the development and testing of approaches that will provide evidence to guide the implementation of evidence-based cancer control interventions. It is expected that research strategies will describe the cancer control problem and context in which evidence-based interventions are being implemented, as well as identify the implementers who will be delivering the interventions.

Provide an overview of the proposed Center. Address all the specific aspects indicated below using the sub-sections as defined:

Sub-section A) U54 Overview and Significance. Describe the overarching organizational framework and vision of the proposed U54 Center, its scientific focus, strengths, and leadership in the research field. Describe how the Center and the investigator team will collectively support the overarching goal of the Center, outlining multi-disciplinary and multi-institutional collaborations, as applicable.

In this sub-section address the following aspects.

• Describe the overall vision of the proposed U54 Center and the significance of the chosen research theme to the needs of the LMIC country(ies) where the research is taking place;
• Describe how the proposed U54 Center will synergize the chosen theme across the LMIC sites and institutions involved;
• Provide background information on the LMIC context (e.g., cancer control challenge, setting, target population, relevant stakeholders) to be included in the Center’s work, and a management plan describing the synergy among the cores and research projects;
• Address the process by which the Center will move the scientific agenda forward; the involvement of the stakeholders; adoption of innovative methodologies to build research capacity; and inform efforts to improve cancer care and coordination in LMIC-based settings;
• Provide a narrative that describes the anticipated contributions of the proposed U54 Center to the scientific knowledge about cancer control implementation science, especially how it will improve our understanding of methods to promote the adoption, integration, and sustainment of evidence-based cancer control interventions in the LMIC(s) participating in the proposed U54 Center;
• Address specifically how the outcomes of the proposed research may contribute to reducing the burden of cancer in LMICs; and
• Address the vision of the proposed U54 Center for enhancing professional development activities for LMIC investigators who are early career or new to implementation science.

Sub-section B) Collaborative Experiences and Research Team. Applicants are expected to describe a plan to manage and coordinate all Center research projects and research capacity-building activities, within a cohesive organizing framework, including training, evaluation, networking, and dissemination. Applicants must describe activities designed to establish sustainable relationships with LMIC-based implementing institutions or organizations and to promote participation throughout the research process, including, development of protocols and survey instruments, understanding contextual barriers and processes, and developing and testing implementation strategies. Summarize the major collective strength of the research team in the proposed area of research. Without repeating information from individual biosketches, explain how the specific expertise of team members will be used to advance the proposed research program. Describe the environments (e.g., academic or other research) of the research team members and how they will support the mission of the proposed Center.

In this sub-section the following items must be addressed.

• Collaborative Experiences (do not repeat information in biosketches)
  • Describe the overall collaborative experiences of the participating U54 Center investigators in implementation science, cancer or other relevant areas. Specifically describe in detail how the PDs/PIs previously collaborated in those areas and their expertise in managing multi-project initiatives;
  • Describe how those collaborations provide a foundation for substantially increased scientific knowledge and improved in-country research capacity.
• U54 Center Makeup:
  • Describe the structure of the proposed U54 Center and the roles and responsibilities for the U54 Center leaders;
  • Provide specific evidence of equal and shared partnership; this should include evidence of a balanced distribution of leadership and responsibilities for research projects and cores; and
  • Outline the overall leadership composition, plan/strategy, structure/organization for the U54 Center and the roles and responsibilities of the U.S. and LMIC investigators in managing the U54 Center and in accomplishing the proposed goals of the U54 Center. Specifically include a description of the roles of each PD/PI in supporting the goals of the proposed U54 Center.

Sub-section C) Overview of Research Projects. Identify the overall focus of the Center research program. Outline the rationale for the proposed research projects, and reasons for their inclusion. Highlight the innovative aspects of all the proposed projects, as applicable.

In this sub-section the following elements must be addressed:

• Explain how the scientific aims and goals of the proposed U54 Center will synergize across the different partners;
• Outline how the research projects and cores will integrate scientifically; and
• Define the goals and strategies of the proposed U54 Center for increasing research capacity in the partnering LMICs and in developing scientific leadership in the U.S. and LMICs.

Letters of Support: All letters of support relevant to the overall application should be included here. Letters of support must be provided from the leadership of each of the participating institutions to detail the institutional resources and personnel commitments to support the proposed U54 Center activities. Include letters from investigators who will serve as consultants or collaborators but with no budgeted efforts.

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

The following modifications apply:

• A Resource Sharing Plan should be provided only under the Overall component but it should cover all the activities proposed for the Center.
• All applications, regardless of the amount of direct costs requested for any one year, must also include a Data Sharing Plan only under the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative and Engagement Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative and Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Title: Descriptive Title of Applicant's Project (use "Administrative and Engagement Core")
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative and Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative and Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative and Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative and Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The contact PD/PI must be designated as Administrative and Engagement Core lead and other PDs/PIs as co-leads.

Budget (Administrative and Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

PD/PI Effort Commitment. Any PD/PI (whether designated as contact or not) must commit a minimum of 1.2 person-months effort per year to the award. This commitment cannot be reduced in later years of the award. Note that this is a minimum effort level that should be increased as appropriate to meet the needs of the work. The budget should account for the efforts of other Core personnel (e.g., Core administrator) and a statistician. The budget should include travel funds for the PD(s)/PI(s) and other senior investigators to attend the annual GlobalISE Cancer Control Consortium Steering Committee meeting and participate in other Consortium-related activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative and Engagement Core)

Specific Aims: Describe how the Administrative and Engagement Core will coordinate activities of the Center and support engagement of stakeholders.

Research Strategy: Applicants are expected to describe a plan to manage and coordinate all Center research projects and research capacity-building activities, within a cohesive organizing framework, including training, evaluation, networking, and dissemination. Applicants must describe activities designed to establish sustainable relationships with LMIC-based implementing institutions or organizations and to promote participation throughout the research process, including, development of protocols and survey instruments, understanding contextual barriers and processes, and developing and testing implementation strategies. Describe the anticipated roles of the Administrative and Engagement Core. Address the specific aspects indicated below using the sub-sections as defined:

Sub-section A. Core Structure. Outline the organization and function of the Administrative and Engagement Core. Describe the plans for coordination and communication with the Center and NCI scientific staff.

Sub-section B. Leadership and Center Organization. Outline the organization of the leadership structure and overall Center structure (provide respective organizational diagrams). Describe the lines of responsibility.

Sub-Section C: Coordination and Partnership Activities:

Describe how the Administrative and Engagement Core will oversee the overall administration, coordination and management of the U54 Center. Specifically, applicants must address the following aspects:

• Provide details on the responsibilities of the Administrative and Engagement Core in supporting the PDs/PIs, project and Core leaders, and any personnel involved in managing the U54 Center.
• Describe how the Administrative and Engagement Core will support administrative activities (e.g., workshops, teleconferences, personnel matters) of the U54 Center.
• Provide a plan for outreach, engagement, and collaboration among partners and external stakeholders.
• Describe activities designed to establish sustainable relationships with LMIC-based implementing institutions or organizations and to promote participation throughout the research process.
• Describe the process that the U54 Center will use to disseminate information to external entities (e.g., website, newsletter).
• Articulate the process for communicating with members of the U54 Center, decision making, and conflict resolution. It should include contingency plans addressing solutions to setbacks and delays including those related to logistics, ethical approvals, travel/visa issues and other possible hurdles in developing the U54 Center.

Sub-Section D: External Advisory Panel.

Address the following aspects:

• Explain how the proposed U54 Center will convene and organize the required External Advisory Panel to advise the U54 Center leadership.
• Outline your vision on how such a Panel may serve as a bridge between the specific research to be conducted at a given U54 Center and the needs of the involved communities at large.
• Provide details on the anticipated composition of the External Advisory Group and the rationale for considering specific types of experts and stakeholders (such as policy makers, health education specialists, institutional and government leaders, key opinion leaders and community advocates from the LMICs). When discussing the potential members of the group, do not mention any specific names; rather just indicate the desirable expertise/profiles. In addition, do not contact potential members until after the peer review process is completed.
• Outline how the feedback from the External Advisory Panel will be sought and implemented by the U54 Center.

Specifically describe how the interaction between the U54 Center and its External Advisory Group may help identify research directions and/or research outcomes that may better address community needs and/or inform health policy changes.

Letters of Support: Include letters of support as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: Resource Sharing Plans should only be included in the Overall component of the application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative and Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Capacity Building Core

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Research Capacity Building Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (use "Research Capacity Building Core")
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Capacity Building Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Capacity Building Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Capacity Building Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Capacity Building Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Capacity Building Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Capacity Building Core)

Specific Aims: Describe the strategy and methods to be used for building sustainable research capacity to conduct cancer control implementation science.

Research Strategy: The Research Capacity Building component is to build sustainable research capacity to conduct and apply implementation science in LMICs, including the designated LMIC(s) where the Center research is to be conducted. The application should describe a coherent plan for capacity building that is integrated across the Center’s activities and demonstrates relevance to the theme and the LMIC setting. Applicants are encouraged to develop innovative models for enhancing the skills of researchers to conduct implementation science for cancer control in LMICs. Highlight any novel features of the capacity-building component for building regional capacity.

Applicants should provide a concise description of the aims for building sustainable research capacity to conduct cancer control implementation science and a description of the career development and training activities to be made available through this Core. Description of individual candidate career development projects in the application are not recommended. NCI anticipates making additional funds available for pilot projects as part of the GlobalISE Cancer Control consortium activities. The plan for the Research Capacity-Building Core should include and detail the process (e.g., for solicitation, submission, review, and award) by which the Center will decide upon and develop pilot projects to provide career enhancement opportunities for early-stage investigators.

Funds for the Research Capacity Building Core should be included in the overall budget of the application. All trainees should be from the center’s geographic region(s). Funds may not be used to support an academic degree program.

Outline plans for a range of other research-related activities and/or available opportunities that may enhance investigators' skills and advance their progression towards becoming independent investigators. Activities/opportunities to consider include (but are not limited to):

• exposure to various research-associated activities (periodic attendance to relevant scientific conferences and presenting own research results, participation in institutional/departmental workshops, seminars, journal clubs, etc.);
• facilitated access to skills enhancing courses, workshops (e.g., in scientific writing, grantsmanship, mentoring/leadership); and/or
• any applicable approaches for gradually increasing responsibilities of junior investigators involved (commensurate with the skills and level of a given individual).

Letters of Support: Include letters of support as appropriate.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Capacity Building Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Projects

When preparing your application in ASSIST, use Component Type "Projects".

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Starting with "Research Project 1" or "Research Project 2" or "Research Project 3)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Projects)

Specific Aims: Outline the Specific Aims of the proposed Research Projects and explain how these aims contribute to the overall research theme of the U54 Center.

Research Strategy: Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, Approach, Environment) defined in the SF424 Application Guide with additional guidance as defined below.

Applicants must describe the LMIC context(s) in which the proposed research will be conducted and highlight how the proposed research has potential to facilitate the broader implementation of effective interventions in LMICs and other low-resource settings. Describe any preliminary data regarding the implementation strategies to be tested, as well as the use of relevant implementation science frameworks or theories. Studies must be suitable for the intended LMIC context(s), with local public health priorities and resource availability informing the design and implementation of the cancer control strategy. Applicants are encouraged to use suitable evaluation frameworks to assess the potential of the intervention to be scaled up.

Letters of Support: Include letters of support as appropriate.

Resource Sharing Plan: Resource Sharing Plans should only be included in the Overall component of the application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Post Submission Materials

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

Section V. Application Review Information

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 FOA, note the following:

The focus of this initiative is to build a consortium of implementation science centers in low- and middle-income countries (LMICs). This initiative intends to support implementation science research capacity-building activities, including research projects that will develop, adapt, and test implementation strategies to deliver evidence-based interventions, tools, and policies for cancer control in LMICs. The projects must generate data for implementation strategies applicable for cancer control needs relevant to LMIC contexts. Projects that are well integrated into LMIC health systems and other care settings in the community and have potential for scale-up and sustainability will be prioritized.

Scoring: Reviewers will provide an overall Impact Score for the entire Center (Overall) and adjectival ratings for individual components (Administrative and Engagement Core, Research Capacity Building Core, and Research Projects).

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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).

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 to this FOA:

How appropriate are the U54 Center's choices of research projects and plans for cores for advancing the LMIC institutions as independent research centers for implementation science in the region? How meaningful an impact are the advancements in the areas corresponding to the U54 Center research theme expected to have in the adoption, integration, and/or sustainment of evidence-based cancer control interventions in the LMIC settings? How sufficient are the proposed activities of the U54 Center for advancing research independence of LMIC institutions and their investigators? How well does the proposed U54 Center plan to develop resources in research and professional development of junior investigators in the U.S. and in LMICs? How adequate are the U54 Center’s plan for synergizing the goals across different LMIC institutions where relevant?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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 to this FOA:

For projects that include both LMIC and U.S. MPIs or investigators: How complementary and appropriately balanced are the expertise and backgrounds of investigators from the partnering institutions in the LMICs and the U.S. for the goals of the U54 Center and the goals of the entire initiative? How equitable are the division of leadership responsibilities between the LMICs and U.S. investigators? In the context of the documentation for prior collaborations across the PDs/PIs and other senior investigators, how likely is it that the Center’s multi-institutional leadership will interact efficiently and productively? How well does the team's expertise highlight sufficient knowledge of the social and cultural contexts of the LMIC settings with appropriate participation and leadership by LMIC investigators, key personnel, and implementation partners?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

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?

Specific to this FOA:

U54 Center Integration: How well do the proposed research projects fit into the overall goals and the scientific theme of the U54 Center? How adequate is the integration of the professional enhancement activities with the proposed research? How clearly articulated and well-integrated are the contributions of all components to the U54 Center?

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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

Specific to this FOA:

For applications involving both LMIC and U.S. MPIs or investigators: How complementary and appropriately balanced are the teams and resources available at the partnering institutions in LMICs and the U.S. for the goals of the U54 Center and the goals of the entire initiative? How well are the responsibilities equitably divided across the LMICs and U.S. institutions to take advantage of respective environments in each participating institution? How well does the proposed research team demonstrate strong partnerships with the LMIC institution(s) including relationships with diverse LMIC stakeholders (policymakers, community workers, and implementers)? How adequate is the plan for positioning the applicants to disseminate study results such that they inform broader scale-up and sustainability toward significant public health impact in LMICs?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Resource Sharing Plans

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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.

Scored Review Criteria - Cores and Research Projects

For each of the Center's components below (i.e., Administrative and Engagement Core, Research Capacity Building Core, and Research Projects), reviewers will provide an overall adjectival rating. Criterion scores will not be provided for the Cores and the Research Projects. Reviewers will consider the following aspects while determining the scientific and technical merit of each component.

Review Criteria - Administrative and Engagement Core

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Administrative and Engagement Core but will give only one adjectival rating (criterion scoring is not used for this component):

• How well matched is the proposed Administrative and Engagement Core to the needs of the U54 Center. How appropriate are the proposed management plans for scientific administration as well as fiscal administration, procurement, regulatory, and personnel management?
• How adequate are the plans for establishing the External Advisory Panel and its role in the U54 Center?
• How sufficient are proposed activities for strengthening research administration to address the needs of the LMIC institutions?
• How sufficient are the plans for engagement of local stakeholders, including implementers, in the research design and conduct?
• How well integrated is the research team with the system delivering the cancer control interventions?

Review Criteria - Research Capacity Building Core

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Research Capacity Building Core but will give only one adjectival rating (criterion scoring is not used for this component):

• How well integrated is this Core with the proposed U54 Center?
• How well does the Core allow the proposed Center, as a whole, to be responsive to the scientific challenge of validating and reproducing Center research results?
• How meaningfully do the proposed research capacity building activities aid the U.S. and LMIC junior investigators on their way towards research leadership in low-resource settings?
• How well do these activities facilitate building cancer control implementation science research capacity at LMIC institutions?
• How relevant and important are the proposed research capacity building activities to the LMIC institutions where they will be conducted?
• How adequate are the U.S. and LMIC institutional commitments to facilitate professional enhancements of U.S. and LMIC junior investigators, and how appropriate and sufficient are they to advance their careers?
• How well matched are the other strategies and activities proposed to enhance research leadership capabilities of U.S. and LMIC junior investigators to the needs of these investigators and are they adequate and justified?
• How adequate are the qualifications, competence, experience, level of commitment, and availability of the Capacity-Building Lead and other staff to guide the capacity-building activities proposed?
• How appropriate and feasible is the proposed timeline for the Capacity-Building tasks and milestones?

Review Criteria - Research Projects

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Research Projects but will give only one adjectival rating for the entire project (criterion scoring is not used for this component).

Significance

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

If successful, does the proposed project demonstrate potential to be scaled up and sustained in the LMIC setting?

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 FOA:

• How appropriate are the expertise of the proposed investigator team in cancer control and implementation science?
• How adequate is the LMIC representation in the research team for the proposed project?
• How sufficient is the team's expertise and knowledge of the social and cultural contexts of the LMIC settings with appropriate participation and leadership by LMIC investigators and key personnel?

Innovation

How adequate or innovative is the proposed project’s plan for use of frameworks, methods, or strategies? How appropriate, feasible, and innovative are the proposed methods for testing implementation strategies in the LMIC setting(s)?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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? How sufficient are quality assurance and quality control measures to avoid study contamination and bias? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in human subjects? Has the LMIC context been adequately described and are the implementation strategies, methods and analysis appropriately matched to the contextual realities?

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? Describe any unique strengths or weaknesses of the Center environment including the Cores and Projects.

Additional Review Criteria - Cores and Research Project

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations - Cores and Research Project

As applicable for the Cores and Projects 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 adjectival rating.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the involvement of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH 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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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: Generaland 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:

• Federalwide 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html 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 FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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 the 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 reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Defining the overall research objectives and approaches of the U54 GlobalISE Cancer Control Center;
• Overseeing and coordinating the efforts of individual U54 GlobalISE Cancer Control Center components and ensuring their optimal integration;
• Overseeing the conduct of the U54 GlobalISE Cancer Control Center research projects and ensuring scientific rigor;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects);
• Overseeing establishment and maintenance of appropriate quality control procedures;
• Overseeing final data analysis and interpretation and preparation of publications;
• Participating as a voting member in the activities of the consortium of U54 GlobalISE Cancer Control Centers Steering Committee;
• Overseeing the Administration of the U54 Center and logistical support for joint activities; and
• Overseeing the preparation of required reports and informing, as needed, the NIH Program staff members concerning U54 Center's progress in research projects and other activities.

All PDs/PIs will be expected to maintain a significant effort commitment not smaller than that stated in the application (at least 1.2 person-months throughout the entire project period).

Participation in the Annual Meeting and Working Groups of the GlobalISE Cancer Control Consortium Investigators: Investigators from all the individual U54 Centers should meet annually to present updates on progress, exchange ideas, develop interregional collaboration, and to discuss problems encountered. It is required that, at a minimum, PDs/PIs and project leaders will attend these meetings. Key Scientific Personnel and trainees will be expected to participate in Consortium working groups to facilitate collaboration and sharing of methods and measures across the Centers.

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

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

An NCI Program staff member(s) will act as a Project Lead Scientist(s) to assist the project team leadership and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (as Project Scientists).

The main responsibilities of substantially involved NCI Program Staff members will include (but will not be limited to) the following aspects:

• Providing technical assistance, scientific input, and assistance in effort coordination across the network of the U54 Centers;
• Promoting collaborations across the different U54 Centers;
• Facilitating interactions of the U54 Centers with other ongoing programs and studies supported throughout the NIH to avoid duplication of effort and encourage sharing and collaboration among the different programs;
• Recommending additional research endeavors within the constraints of the approved research and negotiated budget of the U54 Center;
• Facilitating the Centers Annual Meeting; and
• Participating as a voting member of the GlobalISE Cancer Control Steering Committee.

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

Areas of Joint Responsibility include:

GlobalISE Cancer Control Steering Committee. The GlobalISE Cancer Control Steering Committee will be the Consortium governing body.

The PIs/PDs of awards funded under this FOA will form a new GlobalISE Cancer Control Steering Committee.

The GlobalISE Cancer Control Steering Committee will be composed of the following voting members:

• PDs/PIs and any designated senior investigator so that each Center is represented by a balanced representation of U.S. and LMICs investigators. Each Center will have one vote irrespective of the number of participating members; and
• The NCI Project Scientist(s) will collectively have one vote for the NCI.

In addition, Program Officials and other NIH staff members may participate in the GlobalISE Cancer Control Steering Committee meetings as non-voting members.

The new GlobalISE Cancer Control Steering Committee will meet three times a year; twice by teleconference and once at the annual Investigators Meeting.

The responsibilities of the GlobalISE Cancer Control Steering Committee will include:

• Guiding the overall scientific directions of the GlobalISE Cancer Control Consortium;
• Promoting collaborations across the individual Centers;
• Overseeing, evaluating, and prioritizing the Center pilot projects;
• Interacting with the other Centers in the areas relevant to both initiatives; and
• Facilitating the development and ongoing activities of working groups as part of the Consortium.

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 and composed of: 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.

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 FOAs 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 75and 2 CFR Part 200 Award Term and Condition 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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Gila Neta, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: [email protected]

Vidya Vedham, Ph.D.
National Cancer institute (NCI)
Telephone: 240-276-7272
Email: [email protected]

Andrea Horvath Marques, M.D., MPH, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-646-7320
Email: [email protected]

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

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 202-276-5699
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
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.