Part 1. Overview Information

Key Dates

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

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

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

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The overall goal of this NOFO is to generate evidence-based cancer-related interventions across the cancer control continuum that reflect the diversity of people, places, contexts, and settings in the United States. Applications are expected to propose to test the effect of a cancer-related intervention on at least one cancer-related outcome representing at least one stage of the cancer control continuum using a pragmatic trial study design. Interventions may include (but are not limited to) behavioral interventions, technology-mediated interventions, community-based interventions, healthcare delivery interventions, multilevel interventions, and/or implementation strategies. Outcomes may include (but are not limited to) clinical health outcomes, health status, health behaviors, quality of care, healthcare utilization, community health, and/or implementation outcomes. Contexts may include (but are not limited to) communities, public health organizations, healthcare clinics and practices, and healthcare delivery systems. Interventions may focus on changing outcomes among (but not limited to) individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, and/or communities. Interventions are encouraged to focus on populations experiencing health disparities and healthcare, public health, and community settings with limited resources.

For the purpose of this announcement, pragmatic trials are conceptualized as trials that are intentionally designed to closely reflect the population(s) that would benefit from the intervention, and the context(s) in which the intervention would be provided or delivered. Broadly speaking, pragmatic trials seek to understand if an intervention is effective in “usual” contexts. The ultimate goal of pragmatic trials is to generate evidence that directly informs decision making among key partners and collaborators, including (but not limited to) individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, communities, and policymakers involved in delivering and/or receiving health interventions.

Awards made under this NOFO will initially support a two-year maximum, milestone-driven UG3 phase with a possible transition to a four-year maximum pragmatic trial UH3 phase. Progression to the UH3 phase is based on an administrative review and is dependent on meeting UG3 milestones and additional criteria outlined in this NOFO, availability of funds, and NCI programmatic priorities. Only UG3 grants that have met scientific milestones and feasibility requirements related to the initiation of the pragmatic trial will be considered for transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application following the instructions described in this NOFO.

Key Terms for the NOFO

For the purpose of this NOFO, we define these key terms as follows:

Cancer-related Intervention: An action taken to affect one or more cancer-related outcomes. Cancer-related interventions may include (but are not limited to) a cancer-related behavioral intervention, technology-mediated intervention, community-based intervention, healthcare delivery intervention, multilevel intervention, and implementation strategy.

Cancer-related Outcome: Any cancer-related variable that is hypothesized to change in response to exposure to a cancer-related intervention. Examples of cancer-related outcomes include (but are not limited to) clinical health outcomes, health status, health behaviors, quality of care, healthcare utilization, community health, and implementation outcomes.

Clinical Trial: A clinical trial (“trial”) is a 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. (See NIH clinical trials website for more information). For the purpose of this NOFO, a trial is further specified as including at least one intervention condition and at least one control or comparison condition. Trial designs may be randomized or non-randomized but must be pragmatic.

Explanatory Trial: A trial that is primarily designed to determine the effects of an intervention under “ideal” contexts or circumstances. The primary intent of an explanatory trial is to elucidate or test biological or social mechanisms.

Health Disparity: A health disparity (HD) is a health difference that adversely affects disadvantaged populations, based on one or more of the following health outcomes: (1) Higher incidence and/or prevalence and earlier onset of disease, (2) higher prevalence of risk factors, unhealthy behaviors, or clinical measures in a causal pathway of a disease outcome, (3) higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized measures, (4) premature and/or excessive mortality from diseases where population rates differ, and (5) greater global burden of disease using a standardized metric. (See National Institute on Minority Health and Health Disparities website for more information).

Health Disparity Populations: Racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions. (See National Institute on Minority Health and Health Disparities website for more information).

Implementation Strategy: Methods or techniques used to enhance the adoption, implementation, and sustainability of an evidence-based clinical or public health program or practice. For the purpose of this NOFO, we use the term ‘intervention’ to also include (but not be limited to) an implementation strategy.

Minority Health: Minority health (MH) refers to the distinctive health characteristics and attributes of racial and/or ethnic minority groups, as defined by the U.S. Office of Management and Budget (OMB), that can be socially disadvantaged due in part to being subject to potential discriminatory acts. (See National Institute on Minority Health and Health Disparities website for more information).

Minority Health Populations: Minority racial groups including American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or other Pacific Islander. Minority ethnicity includes Latino or Hispanic. (See National Institute on Minority Health and Health Disparities website for more information).

Multilevel Intervention: An intervention that includes components that target change at two or more levels of individuals, healthcare or public health providers, or healthcare/community settings and also measures outcomes at two or more levels. For the purpose of this NOFO, we use the term ‘intervention’ to also include (but not be limited to) a multilevel intervention.

Pragmatic Trial: A trial that is primarily designed to determine the effects of an intervention under “usual” contexts or circumstances. The primary intent of a pragmatic trial is to generate information that directly informs decision making among key partners and collaborators, including (but not limited to) individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, communities, policymakers, and/or others involved in delivering or receiving health-related interventions and services.

Background

Decades of research on cancer have led to the development of hundreds of evidence-based cancer-related interventions, practices, programs, clinical practice guidelines, implementation strategies, and cancer care delivery models and approaches (collectively referred to herein as “interventions”). Examples of sources and compendiums of effective cancer-related interventions include (but are not limited to) the NCI-supported Evidence-Based Cancer Control Programs (EBCCP), U.S. Preventive Services Task Force, National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®), The Guide to Community Preventive Services, and Cochrane Reviews, among others. Collectively, cancer-related interventions have significantly improved cancer-related outcomes and population health.

Despite these advances, there remain some notable gaps in the content and focus of evidence-based, cancer-related interventions across the cancer control continuum. Specifically, there is a need for effective interventions that focus on populations experiencing health disparities (e.g., racial and ethnic minority populations), interventions that address relatively new and emerging cancer-related issues (e.g., economic hardship), interventions that leverage novel delivery modalities (e.g., telehealth), and interventions that can be delivered for populations in diverse locations (e.g., rural areas). There is also a need for increasing the number and scope of implementation strategies (e.g., to increase use of evidence-based interventions in settings with limited resources) and cancer care delivery models or approaches (e.g., care coordination). Filling gaps in our current intervention portfolio is essential for maximizing the equitable impact of such interventions on improving health for diverse populations across a range of community and clinical contexts nationwide.

Clinical trials (“trials”) are a rigorous research study design in which many health-related interventions are tested, the results of which can lead to the identification of effective interventions that can improve health-related outcomes. Despite their essential role, trials are sometimes criticized for relatively poor generalizability and applicability to everyday individuals, contexts, and settings. Although trials emphasize internal validity, they are sometimes designed in ways that place less emphasis on external validity, or the extent to which trial results accurately reflect and are generalizable to the populations and settings in which the results are intended to apply and the intervention is intended to be used. To address this criticism, structured approaches have been developed to help design trials that emphasize both rigor and applicability by optimizing both internal and external validity.

One way of conceptualizing trials is along a continuum from more explanatory to more pragmatic. On one end of the continuum, explanatory trials are those that emphasize internal validity. Explanatory trials seek to understand if an intervention is effective under “ideal” contexts, often characterized as highly resourced, tightly controlled, and conducted in somewhat artificial or atypical settings. Broadly speaking, these types of trials are mostly concerned with understanding and testing hypotheses on the existence of particular biologic or social mechanisms of action. On the other end of the continuum are pragmatic trials, which emphasize more of a balance between internal and external validity. Pragmatic trials seek to understand if an intervention is effective in “usual” contexts that closely reflect the individuals, settings, and contexts in which the intervention is intended to be used to improve population health. Broadly speaking, these types of trials are mostly concerned with generating evidence that directly informs decision making among key partners and collaborators, including (but not limited to) individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, communities, policymakers, and/or others involved in delivering or receiving health-related interventions.

Design elements of a trial can help determine where along the explanatory-pragmatic continuum the trial falls, and thus reflect the overall purpose and intent of the trial. Examples of trial design elements include (but are not limited to) participant eligibility criteria, recruitment strategies, setting or context, primary outcome, data collection, data sources, and research question(s). Intentional decisions about how much flexibility there should be for these and other trial design elements during the trial design phase make the trial more or less pragmatic in overall purpose and intent.

Many resources are available to help design and conduct pragmatic trials of health-related interventions. These include articles, webinars, workshops, and planning tools (e.g., Pragmatic Explanatory Continuum Indicator Summary-2 [PRECIS-2]; GetReal Trial Tool); extensive web-based textbooks (e.g., NIH Pragmatic Trials Collaboratory Living Textbook); and video learning libraries (e.g., National Institute on Aging [NIA] IMbedded Pragmatic Alzheimer’s disease and AD-Related Dementias Clinical Trials [IMPACT] Collaboratory), among others.

Specific Research Objectives and Requirements

Through this NOFO, NCI solicits applications that propose to use a pragmatic trial to test a cancer-related intervention to improve at least one cancer-related outcome representing at least one stage of the cancer control continuum. Applications should propose to develop and test a cancer-related intervention that is missing, largely absent, or underrepresented in the current evidence base of effective interventions. Applications are encouraged to focus on including minority health populations and populations experiencing health disparities as well as settings, communities, and contexts with limited resources.

Examples of cancer-related interventions that could be proposed in response to this NOFO include (but are not limited to):

• Interventions to improve cancer survivorship care delivery in primary care settings.
• Interventions to improve physical health and function among cancer survivors living with multiple chronic health conditions.
• Interventions to alleviate economic hardship among cancer survivors.
• Interventions to increase knowledge and enhance health literacy of complex cancer information.
• Interventions to integrate shared decision making into screening for lung, colorectal, and prostate cancer.
• Interventions to reduce exposure to environmental carcinogens.
• Interventions to improve cancer genetic counseling, testing uptake, and follow-up care.
• Implementation strategies to promote early integration of specialty palliative care into care of patients with advanced cancer.
• Implementation strategies to integrate geriatric assessment and management into care of older adults undergoing cancer treatment.
• Implementation strategies for bundled evidence-based interventions in healthcare and public health settings.

UG3/UH3 Cooperative Agreement Award Mechanism

This NOFO will utilize a two-phase cooperative agreement (UG3/UH3) mechanism. Awards made under this NOFO will initially support a two-year maximum, milestone-driven UG3 phase, with a possible transition to a four-year maximum pragmatic trial UH3 phase. The UG3/UH3 application must be submitted as a single application following the instructions described in this NOFO. Milestones to be accomplished in the UG3 phase for transition to the UH3 phase as well as annual milestones for the UH3 phase must be proposed by the PI in the application.

UG3 Phase

The UG3 phase of the application must describe all preparatory activities necessary for conducting the pragmatic trial during the UH3 phase. These preparatory activities include those related to (1) piloting and refining the cancer-related intervention and (2) revising and finalizing plans and processes necessary for conducting the pragmatic trial.

Specific activities related to piloting and refining the cancer-related intervention include (but are not limited to):

• Pilot testing the cancer-related intervention;
• Adapting and/or refining the intervention based on qualitative, quantitative, and/or mixed methods data collected during pilot testing; and
• Finalizing the intervention in collaboration with key partners and decision makers.

Specific activities related to revising and finalizing plans and processes necessary for conducting the pragmatic trial include (but are not limited to):

• Pilot testing and revising recruitment strategies, data collection methods, and outcomes measures;
• Updating power analyses and sample size estimates;
• Refining informed consent documents (where applicable);
• Demonstrating continued and meaningful engagement of key partners and collaborators;
• Finalizing design elements of the pragmatic trial;
• Developing detailed plans and processes for data harmonization and data sharing in partnership with key collaborators and in accordance with NIH policies; and
• Finalizing the pragmatic trial protocol in preparation for submitting for IRB and regulatory approval.

UG3 Phase to UH3 Phase Transition

Utilization of milestones is a key characteristic of this NOFO. A milestone is defined as a scheduled event in the project timeline signifying the completion of a major project stage or activity. Applications must include well-defined milestones for the UG3 phase and annual milestones for the UH3 phase. Milestones for the UG3 phase must be objectively defined and quantifiable to ensure clear demonstration that the proposed milestones were met at the time of the transition request.

At the completion of the UG3 phase, the applicant will be required to submit a detailed transition request to the UH3 phase. An administrative review will be conducted by NCI program staff to decide whether a UG3 phase grant will be transitioned into a UH3 phase grant based on the following criteria:

• Successful achievement of defined milestones in the UG3 phase;
• Successful completion of all preparatory activities necessary for launching the pragmatic trial at the beginning of the UH3 phase;
• Potential for successfully conducting and completing the pragmatic trial during the UH3 phase;
• Availability of funds; and
• Programmatic priorities.

UH3 Phase

The UH3 phase of the application must include plans to test the effect of a cancer-related intervention on a cancer-related outcome in a pragmatic trial. The application must contain detailed information about the proposed pragmatic trial.

The UH3 phase will include activities necessary to achieve the following goals:

• Successfully conduct and complete all aspects of the proposed pragmatic trial, from the initial IRB protocol and regulatory approval through final data analyses, study close-out, dissemination of study results, and data sharing; and
• Identify whether the proposed cancer-related intervention has a statistically significant impact on improving the cancer-related outcome as tested in the pragmatic trial.

Continued funding during the UH3 phase will be dependent upon meeting annual UH3 milestones. It is expected that the trial will be completed within the UH3 grant period. The trial must meet all applicable NIH and Office for Human Research Protections (OHRP) policy requirements.

Non-Responsive Applications

The following types of activities remain outside the scope of this NOFO. Applications proposing them will be considered non-responsive to this NOFO and will not be reviewed.

• Applications that propose to test cancer-related therapies, imaging, diagnostics, biologics, or devices (e.g., first-in-human studies or drug/device safety trials).
• Applications that propose a pragmatic trial that does not have at least one intervention condition and at least one control or comparison condition.
• Applications lacking milestones for the UG3 phase and UH3 phase.

Additional Information

Pre-application Information Session: NIH staff will hold a teleconference for potential applicants to answer questions related to this NOFO. Time, date, and dial-in information for the call will be announced at a later date in the NIH Guide Notice.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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:

Wynne E. Norton, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6875
Email: [email protected]

Page Limitations

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

For this specific NOFO, the Research Strategy section is limited to 25 pages.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Describe the overall goals for the entire application. Provide a rationale and description of how the application addresses a gap in the evidence base of cancer-related interventions, and how addressing that gap will impact public health. Include distinct aims for the UG3 phase and the UH3 phase, and clearly label them as UG3 specific aims and UH3 specific aims.

Research Strategy: Applicants should describe both the UG3 phase and the UH3 phase using the standard sub-sections of Research Strategy defined in more detail in the SF424 Application Guide with additional guidance below.

Significance: Explain the significance of the health problem and justify why the proposed cancer-related intervention is likely to have an impact on the health problem. Provide evidence that the health problem and the cancer-related outcome are important to and a priority among key collaborators and decision makers.

Investigator: Demonstrate that the research team has the multidisciplinary scientific expertise necessary for piloting and refining the cancer-related intervention and conducting and completing the proposed pragmatic trial. Demonstrate that the appropriate collaborators and decision makers are involved in the proposed study, and provide evidence of successful collaboration between the research team and the proposed key partners and decision makers.

Innovation: Discuss how the proposed intervention fills a gap in the evidence base of cancer-related interventions. Provide compelling information (and include data, where applicable) that demonstrates that the proposed cancer-related intervention is missing, largely absent, or underrepresented in the current evidence base of effective interventions.

Approach: This section should include a description of the approach needed to accomplish the objectives for the UG3 phase and the UH3 phase. The approach should be divided into the UG3 phase and the UH3 phase and address the following for each phase:

UG3 Phase: The UG3 part of the application must describe the proposed cancer-related intervention and the activities associated with preparing for the pragmatic trial in the UH3 phase. . Specifically, the application should:

• Describe the proposed cancer-related intervention to be tested in the pragmatic trial;
• Provide preliminary quantitative data that the proposed cancer-related intervention has the potential to have a significant impact on improving the cancer-related outcome;
• Provide evidence that the proposed cancer-related intervention is appropriate for the target population and the setting;
• Explain why a pragmatic trial is the appropriate next step for testing the cancer-related intervention;
• Describe how the cancer-related intervention will be pilot tested and refined in preparation for conducting the pragmatic trial;
• Describe activities related to revising and finalizing plans and processes in preparation for conducting the pragmatic trial;
• Describe how health equity is incorporated into the content, focus, and components of the cancer-related intervention; and
• Describe how relevant theories, models, and/or frameworks have informed the initial development, design, and content of the cancer-related intervention.

UH3 Phase: The UH3 part of the application must describe the proposed pragmatic trial. Specifically, the application should:

• Propose a pragmatic trial to test the effect of a cancer-related intervention on a cancer-related outcome;
• Describe and justify the design elements of the pragmatic trial;
• Describe the decision-making process with key collaborators regarding design elements of the pragmatic trial;
• As part of the pragmatic trial, include an intervention condition and a rigorous control or comparison condition prospectively identified and preferably assigned by randomization. A non-randomized design may be proposed instead of a randomized design. Appropriate justification for use of a randomized or non-randomized design and demonstration of rigor should be included;
• Justify the selection of the control or comparison condition;
• Without duplicating information provided in the PHS Human Subjects and Clinical Trials Information Form, provideinformation about and justification for the proposed statistical and data analytic plans for the pragmatic trial, including (but not limited to) power analyses, effect size estimates, sample size calculations, analyses for hypothesis testing, statistical approaches for handling missing data, and attrition. Applicants are strongly encouraged to consult available resources for guidance when developing statistical and data analytic plans (e.g., NIH Pragmatic Trials Collaboratory Design chapters; NIH Research Methods Resources); NCI Cluster Randomized Designs in Cancer Care Delivery Research Short Course);
• Demonstrate that the pragmatic trial is adequately powered to detect statistically significant differences in the cancer-related outcome between the intervention condition and the control or comparison condition; and
• Use reliable and validated measures to assess the cancer-related outcome.

Applicants should address how they will adhere to the NIH Policy on Good Clinical Practice Training. This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice.

Milestones and Timelines

A timeline including milestones is required for all phases of the application (UG3/UH3). A milestone is defined as a scheduled event in the project timeline signifying the completion of a major project stage or activity. Milestones will be used to evaluate the application in peer review as well as in consideration of the awarded project for funding of non-competing award years.

The application must include a section of proposed milestones that are clearly specified, well-defined, quantifiable, scientifically justified, and include objective criteria to allow for assessment of progress and success. For UG3 milestones, applicants should delineate what they propose to achieve in order to proceed to the UH3 phase. The milestones should also include a timeline, a discussion of the suitability of the milestones for assessing success in the UG3 phase, and a discussion of the implications of successful completion of these milestones for the proposed UH3 phase. Annual milestones for the UH3 phase must also be included in the application, although it is understood that timelines and milestones for conducting the trial in the UH3 phase that are proposed in the application will evolve as activities in the UG3 phase progress.

Health Disparities: If applicable to the type of research projects being proposed, the Research Strategy must address how minority health, health disparity populations, or data will be integrated into the proposed studies.

Letters of Support: Applications must include letters of support from key partners and decision makers collaborating on the project. Key partners and decision makers may include (but are not limited to) those from or representing patients, community advisory boards, practitioners, healthcare systems, public health departments, professional associations, clinics, hospitals, community-based organizations, community leaders, and others.

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

Other Plan(s): 

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

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

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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.

2. Review and Selection Process

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned 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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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: Recipient 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).

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

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

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

The PD(s)/PI(s) of each award will have the primary authority and responsibility for the project as a whole, including determining research approaches, designing protocols, setting project milestones in consultation with NCI staff, ensuring scientific rigor, conducting specific studies, analysis and interpretation of research data, and preparation of publications.

Specific rights and responsibilities will include the following:

• Overseeing the overall budget, activities, and performance of the project;
• Conducting the scientific research in the project, reporting progress and milestones or objectives to NCI staff, reporting results to the scientific community, and disseminating approaches, methods, models, and tools broadly;
• Participating in a cooperative, interactive, and collaborative manner with NCI staff, including those outlined below under “NIH Responsibilities”;
• Submitting a detailed transition request for the phase, outlining progress, accomplishment of milestones, and detailed plans, budget, and annual milestones for the phase. Note that funding of the phase cooperative agreement does not guarantee support of the phase;
• Submitting materials and updates to the NCI on study progress, accomplishments, and challenges as requested;
• Facilitating the public release and dissemination of results, data, and other products generated through this award in a timely manner. All PDs/PIs are expected to share data and resources generated through this award in accordance NIH sharing policies and the goals of the NOFO;
• Complying with OHRP and FDA regulations concerning the protection of human subjects;
• Assuming responsibility and accountability to the applicant organization officials for the performance and proper conduct of the research and administrative functions supported under this NOFO in accordance with the terms and conditions of the award, as well as all pertinent laws, regulations, and policies; and
• Operating in accordance with processes and goals as delineated in the NOFO.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion various activity of the recipients. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to:

• Providing scientific input on pilot testing and refining the proposed cancer-related intervention (e.g., providing methodological and statistical expertise, input on how to refine the intervention based on pilot data, and guidance on finalizing plans and procedures in preparation for the pragmatic trial);
• Providing scientific input on the design elements of the pragmatic trial;
• Providing input on scientific milestones and decisions regarding their finalization;
• Promoting collaborative research efforts by facilitating interactions with relevant NCI- and NIH-sponsored programs, projects, and centers; and
• Contributing to scientific manuscripts and other scientific and scholarly activities (e.g., conference presentations) resulting from the project.

Additionally, an NCI Program Director acting as the NCI 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:

None, all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Implementation Science
Wynne E. Norton, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6875
Email: [email protected]

Health Disparities and Health Equity
Amy Kennedy, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-781-3335
Email: [email protected]

Shobha Srinivasan, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: [email protected]

Cancer Survivorship
Emily Tonorezos, MD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5048
Email: [email protected]

Behavioral Research 
Frank Perna, EdD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6782
Email: [email protected] 

Epidemiology and Genomics Research 
Nonniekaye F. Shelburne, CRNP, MS, AOCN
National Cancer Institute (NCI)
Telephone: 240-276-6897
Email: [email protected]

Healthcare Delivery Research 
Sarah Kobrin, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6931
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

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

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.