Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Pragmatic Trials across the Cancer Control Continuum (UG3/UH3 Clinical Trial Required)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices

NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
PAR-22-256
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.399
Funding Opportunity Purpose

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) intends to accelerate the development of evidence-based cancer-related interventions that reflect the diversity of people, places, contexts, and settings in the United States. Specifically, this FOA will support research that tests the impact of cancer-related interventions on cancer-related outcomes across the cancer control continuum using a pragmatic trial study design. This FOA will use the UG3/UH3 phased cooperative agreement mechanism. The UG3 phase will support refining the cancer-related intervention and finalizing study-related activities in preparation for conducting the pragmatic trial during the UH3 phase.

Key Dates

Posted Date
November 23, 2022
Open Date (Earliest Submission Date)
January 14, 2023
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 14, 2023 March 14, 2023 Not Applicable June 2023 October 2023 December 2023
June 14, 2023 July 14, 2023 Not Applicable October 2023 January 2024 April 2024
October 17, 2023 November 17, 2023 Not Applicable February 2024 May 2024 July 2024
February 14, 2024 March 14, 2024 Not Applicable June 2024 October 2024 December 2024
June 14, 2024 July 14, 2024 Not Applicable October 2024 January 2025 April 2025
October 17, 2024 November 17, 2024 Not Applicable February 2025 May 2025 July 2025
February 14, 2025 March 14, 2025 Not Applicable June 2025 October 2025 December 2025
June 14, 2025 July 14, 2025 Not Applicable October 2025 January 2026 April 2026
October 17, 2025 November 17, 2025 Not Applicable February 2026 May 2026 July 2026

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

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

Expiration Date
November 18, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The overall goal of this FOA 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 FOA 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 FOA, 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 FOA.

Key Terms for the FOA

For the purpose of this FOA, 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 FOA, 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 FOA, 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 FOA, 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 FOA, 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 FOA 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 FOA will utilize a two-phase cooperative agreement (UG3/UH3) mechanism. Awards made under this FOA 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 FOA. 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 FOA. A milestone is defined as a scheduled event in the project timeline signifying the completion of a major project stage or activity. Applications mustinclude well-defined milestones for the UG3 phase and annual milestones for the UH3 phase. Milestones for the UG3 phase mustbe 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 FOA. Applications proposing them will be considered non-responsive to this FOA 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 FOA. Time, date, and dial-in information for the call will be announced at a later date in the NIH Guide Notice.

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

Funding Instrument

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

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets may not exceed $500,000 in direct costs per year for the UG3 phase and may not exceed $750,000 in direct costs per year for the UH3 phase.

Award Project Period

The maximum project period is two years for the UG3 phase and four years for the UH3 phase. 

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

Eligible Organizations

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
Foreign Institutions

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

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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, 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 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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.

 

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: wynne.norton@nih.gov

Page Limitations

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

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

Instructions for Application Submission

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) 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.

Other Plan(s):

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

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

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

Appendix:

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

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

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

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). 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.

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 FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be 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.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

Applications in response to this FOA 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.

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.

Overall Impact

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

Scored Review Criteria

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

 

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?

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?

Specific for this FOA:
How well does the application provide an explanation and justification for why the proposed cancer-related intervention is needed and how it fills a gap in the evidence base? How well does the application demonstrate that the cancer-related outcome is important to key collaborators and decision makers (e.g., individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, communities, policymakers, and/or others involved in delivering or receiving cancer-related practices and services)? How well does the study describe the potential impact of the cancer-related intervention on improving a major cancer-related health issue?

 

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?

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?

Specific for this FOA:

How well does the application provide evidence that the investigative team has scientific expertise in cancer-related interventions and pragmatic trials? How well does the application describe the involvement and inclusion of key partners and decision makers (e.g., individuals or patients, caregivers, practitioners, organizations, healthcare systems, public health settings, communities, policymakers, and/or others involved in delivering or receiving cancer-related practices and services) as collaborators in the proposed research?

 

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?

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?

Specific for this FOA:

How well does the application demonstrate that the proposed cancer-related intervention is important yet missing, largely absent, or underrepresented in the current evidence base of effective interventions?

 

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

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

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?

Specific for this FOA:

How well does the application describe the process for piloting and refining the cancer-related intervention as well as revising and finalizing plans and processes necessary for conducting the pragmatic trial? How well does the application describe and justify the design elements of the pragmatic trial? How adequately does this application address Good Clinical Practices compliance?

In addition, for the Milestones Plan -- To what extent do the proposed milestones provide sufficient detail for the planned tasks? To what extent are the milestones clearly defined, feasible, and quantifiable with respect to the proposed activities within the proposed timeframe? How appropriate are the milestones for the UG3 phase and do they reflect the ability to conduct all preparatory activities necessary to launch the pragmatic trial at the beginning of the UH3 phase? How appropriate are the milestones for the UH3 phase and do they reflect the ability to conduct and complete the pragmatic trial?

 

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?

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?

Additional Review Criteria

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

 

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)?

 

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.

 

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.

 

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.

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Applicable.

 

Not Applicable.

Additional Review Considerations

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.

 

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.

Not Applicable

 

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).

 

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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

 

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.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

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. 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.
  • Compliance with resource sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.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: 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

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:

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 and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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.

Cooperative Agreement Terms and Conditions of Award

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) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 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 recipientsis 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the 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 FOA;
  • 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 FOA 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 FOA.
  • 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 award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: one NIH designee and two designees with expertise in the relevant area, chosen by the NCI Cohort Consortium Steering Committee. This special dispute resolution procedure does not alter the recipient'sright to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH 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 75.113 and 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 75 and 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.

Application Submission Contacts

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Implementation Science
Wynne E. Norton, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6875
Email: wynne.norton@nih.gov

Health Disparities and Health Equity
Amy Kennedy, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-781-3335
Email: amy.kennedy@nih.gov

Shobha Srinivasan, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: sriniva2@mail.nih.gov

Cancer Survivorship
Emily Tonorezos, MD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5048
Email: Emily.tonorezos@nih.gov

Behavioral Research
Susan Czajkowski, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5871
Email: czajkows@mail.nih.gov

Epidemiology and Genomics Research
Nonniekaye F. Shelburne, CRNP, MS, AOCN
National Cancer Institute (NCI)
Telephone: 240-276-6897
Email: nshelburne@mail.nih.gov

Healthcare Delivery Research
Sarah Kobrin, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6931
Email: kobrins@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Office of Grants Administration
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

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.

Authority and Regulations

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.

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