Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Funding Opportunity Announcement.

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to support the development and testing of primary care practice (PCP)- and health system-level interventions and strategies to promote high quality care for adult cancer survivors during and/or after cancer treatment. The overall goal of this opportunity is to support high quality care for cancer survivors that integrates primary care from the point of diagnosis forward. Specific emphasis will be placed on primary care delivered to populations experiencing disparities in access and outcomes. This research will inform the critically needed evidence base for delivery of high-quality survivorship care delivered in part by PCPs.

Background

Key Definitions:

• Cancer survivor: Any individual diagnosed with cancer from the time of diagnosis until the end of life.
• Cancer survivorship care: Provides a comprehensive approach to care for individuals diagnosed with cancer, from the point of diagnosis through the balance of life. Care includes surveillance for recurrence and new malignancies, screening and management of physical and psychological side effects, preventive care, management of multiple chronic conditions, improving mental and emotional well-being, promotion of positive health behaviors, and managing late- and long-term conditions as a result of cancer and its treatment.
• Health outcomes: Any physical, social, or psychological outcome that affects well-being. For cancer survivors, these effects may result from their cancer, the cancer experience, and/or anti-cancer treatments.
• Healthcare quality: The degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current evidence and professional knowledge.
• Health system: Collection of primary and specialty-care clinicians and support staff, medical facilities, and organizational structures. Together, these people, institutions, and resources provide the environment for the comprehensive delivery of healthcare services.
• Health systems-level research: Approaches focused on improving the performance of practices and healthcare organizations and may address organizational structures, communication processes, capacity, and processes of health service delivery within and across different care delivery settings.
• Healthcare team: Two or more health professionals, social care professionals, and/or staff who identify as a team and work together to deliver services and/or solve care problems.
• Primary Care: Healthcare services that include but are not limited to disease prevention, disease screening, health promotion, and treatment of illnesses. Primary care providers (PCPs) include physicians (M.D. Medical Doctor or D.O. Doctor of Osteopathic Medicine), nurse practitioners, clinical nurse specialists, and physician assistants in family medicine, primary care, and internal medicine. They advise and treat a range of health-related issues.

The National Academies of Science, Engineering, and Medicine defines healthcare quality as the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current evidence. High-quality primary care is comprehensive, and should address the following domains: effectiveness, efficiency, equity, patient-centeredness, safety, and timeliness. For the 18.1 million cancer survivors in the United States, achieving high quality care is a critical goal from the time of diagnosis forward.

Survivorship care is complex. In 2005, the Institute of Medicine recommended a comprehensive approach to survivorship care, with components including: (1) surveillance for recurrence and new malignancies, (2) screening and management of physical and psychological side effects, and (3) health promotion and preventive care. Care for survivors does not stop with monitoring and managing the impacts of cancer and its treatment, however. There is also a need to assess and manage multiple chronic conditions (in addition to cancer), improve mental and emotional well-being and optimize psychosocial functioning, promote positive health behaviors, and manage late- and long-term conditions. Many of these components of care are managed by primary care providers (PCPs).

Because care for adult cancer survivors is multifaceted, professional organizations have promoted shared care models, where components of care are shared between specialties (e.g., oncologists, cardiologists) and PCPs. Coordinating and delivering shared care is challenging, however, and requires communication between patients and providers, and among multiple providers delivering care. Given the important role that PCPs have in shared care, it is critical to ensure that they are prepared to address the needs of all survivors. An examination of PCPs and practices reveals that, although many currently provide or are interested in providing high quality care for survivors, they experience substantial barriers. For example, providers often do not identify cancer survivors as a distinct category and may not have access to actionable information on diagnosis, treatment history, or recommendations for follow-up care. The challenge of delivering high quality survivorship care is worsened by a shrinking and overburdened PCP workforce, a fragmented health system, patient factors such as variability in health insurance coverage, issues with language and health literacy, and contextual barriers stemming from organizational policies, and neighborhood or community factors such as the availability of affordable transportation. Many of these issues have been exacerbated by the COVID-19 pandemic, which disrupted continuity of care and imposed new challenges. Unfortunately, for survivors, failure to obtain adequate follow-up care can result in adverse outcomes including increased morbidity and mortality.

A growing consensus supports the notion that care of the cancer survivor requires integration of primary care from the time of diagnosis through the end of life. Evidence-based strategies to deliver this care in the primary care setting, however, are limited. Additionally, while there have been efforts to improve PCP capacity and knowledge regarding care for survivors, these initiatives have not resulted in widespread change. Previous efforts have included training programs for interested PCPs, interventions targeting individual PCPs (not practices or health systems), and survivorship care plans, which have not accounted for the ongoing nature of survivorship care. Overall, there is a need to develop, test, and implement effective strategies for widespread systemic impact on care for survivors in primary care.

Specific Research Objectives and Scope of this FOA

The purpose of this FOA is to support studies that develop and test primary care practice- and health system-level interventions and strategies to promote high quality care for adult cancer survivors during and/or after the treatment period. Toward this end, interventions should target primary care practices or health systems that deliver primary care. The goal is to support PCPs in providing the components of cancer survivorship care that are germane to primary care. This research will inform the critically needed evidence base for delivery of high-quality survivorship care provided in part by PCPs.

NCI is particularly interested in applications that address barriers to care that contribute to disparities in health outcomes for cancer survivors, and/or that focus on high-risk groups such as uninsured/under-insured or otherwise underserved survivors, with justification. NCI also seeks to fund a diversity of primary care settings in terms of geographic location and populations served.

Examples of intervention research topics include, but are not limited to, the following:

• Developing and testing methods OR comparing methods for:
  • PCP practices to engage survivors in healthy lifestyle changes;
  • Enhancing coordination and management of treatment-related toxicities and comorbidities;
• Testing the impact of innovative policy, incentive, and educational strategies on PCP involvement in survivorship care;
• Examining the role of novel navigation interventions based in the primary care setting in promoting receipt of survivorship care;
• Evaluating communication or information technology approaches to facilitate care coordination between PCPs and oncology care specialists;
• Developing and testing strategies that seek to promote alignment of primary care workflows with existing survivorship guidelines.

Key considerations:

• All applications should propose interventions that do more than engage individual PCPs or integrate primary care into a cancer center workflow
• Studies supported by this RFA should be conducted in PCP practices or integrated health systems that include primary care
• Applications should focus on the delivery of one or more components of care for cancer survivors through primary care (e.g., surveillance for recurrence and subsequent cancers, behavioral health, monitoring and managing acute and long-term side-effects of cancer and its treatment, management of comorbid conditions, and/or health promotion)
• Applications should incorporate clinically meaningful endpoints, including healthcare utilization, patient-reported outcomes, patient-provider communication, measures of care quality (e.g., guideline-concordant care), implementation outcomes, and/or clinical outcomes
• PCPs should have a leadership role on the investigator team and have direct involvement in the study planning and conduct; study team should also include oncology care providers
• Proposed interventions should integrate other healthcare professionals as appropriate and with justification (e.g., social workers, nurses, patient navigators, physical therapists)
• Applications must describe activities designed to enhance, expand, and sustain partnerships with PCP practices
• Research should focus on PCPs delivering care to any adult survivor group (including adult survivors of childhood cancer) at any stage or time after cancer diagnosis
• Submissions should include a resource and data sharing plan per NIH guidelines

This RFA strongly encourages the following types of studies as appropriate and with justification:

• Applications that propose multi-level research;
• Applications that examine feasibility of widespread adoption, scaling, and sustainability of the interventions being developed and tested;
• Applications that focus on survivors, practices, or organizations that include members of diverse and medically underserved populations (e.g., based on race/ethnicity, socioeconomic status, geographic regions, and/or healthcare settings such as Federally Qualified Health Centers).

Applications Not Responsive to this FOA

The following types of studies are not responsive to this FOA and will not be reviewed:

• Observational studies;
• Studies that test interventions that target individual survivors or providers and do not include a practice or health system-level approach;
• Studies conducting a non-randomized program evaluation of an existing model of survivorship care;
• Studies that focus on interventions to promote single handoffs or transitions between providers and do not aim to improve ongoing care delivered by PCPs;
• Applications focused only on the development or provision of a survivorship care plan;
• Studies that do not include human subjects.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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.

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:

Michelle Mollica, PhD, MPH, RN, OCN
National Cancer Institute (NCI)
Telephone: 240-276-7621
Email: [email protected]

Page Limitations

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

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

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 or Modular 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:

Significance:

• Justification explaining how the proposed research addresses a pressing need or evidence gap pertaining to primary care for adult cancer survivors, as identified in the literature;
• Explanation of how information gained from the project, whether or not successful, will inform future interventions, clinical guidelines, or strategies to improve primary care for adult cancer survivors.

Investigators:

• Applications must include a description of the study team, including the plan for integration of a primary care provider/researcher as part of the leadership team, and oncology care providers as key personnel, as appropriate and with justification.

Approach:

• Applications must include a justification of how the proposed research addresses a pressing need or evidence gap pertaining to primary care for cancer survivors, as identified in the literature. Description should include an explanation of how information gained from the project, whether or not it is successful, will inform future interventions, clinical guidelines, or strategies to improve primary care for cancer survivors.

Resource Sharing Plan:

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan
  • In addition to the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, applicants are required to submit a data sharing plan that is compliant with all NIH data sharing policies and describes how data will adhere to FAIR principles, meaning that it should be Findable, Accessible, Interoperable, and Reusable (FAIR). These principles are also outlined in the NIH Strategic Plan for Data Science. Applicants are encouraged to consider NIH data repositories for sharing data with external investigators. Informed consent must include permission to share de-identified data with the broad research community and deposit to a data repository. The data repository chosen must allow for the data to be publicly accessible or by controlled access, which means to access the data, the individual requesting the data must comply with specific rules and regulations (e.g. dbGaP).

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 evaluated 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.

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

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

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

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.

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 NCI, NIH, 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 FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.

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: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

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

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

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable US Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, US Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR 200, 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 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 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Define the overall research objectives;
• Determine approaches, design protocols, set project-specific objectives (e.g., milestones), and oversee the conduct of the research;
• Ensure compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
• Adhere to the NIH policies regarding intellectual property, data release, and other policies;
• Cooperate with NCI programmatic, technical, and administrative staff;
• Participate as voting member(s) of the steering committee;
• Attend annual meetings, be held either virtually and/or in-person in the Bethesda, Maryland, area;
• In addition to standard annual Research Performance Progress Report (RPPR) submissions, PD(s)/PI(s) may be expected to supply additional progress-related information to the NCI.

The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award.

Recipients are required to provide annual progress reports and descriptive data to NCI, including counts of participants (including current age, vital status, response rates, and losses to follow-up or withdrawals) and a summary of data shared (including the number of requests, approvals, denials, and list of collaborators) when appropriate.

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.

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 Coordinator(s), will coordinate in a centralized fashion various activities of the recipients.

Specific responsibilities of the NCI Project Scientist(s)/Coordinator(s) will include the following aspects as previously stated:

• Participating as voting members on the steering committee;
• Facilitate collaborations between the recipients and other NCI-sponsored programs, investigators, or organizations;
• Assist with the coordination of efforts that may contribute to the projects goals and NCI’s priorities;
• Advise recipients on compliance with NIH policies, such as NIH data sharing policies;
• Attend the steering committee/external advisory board meetings and/or other standing/ad hoc meetings as appropriate;
• Organize and conduct annual meetings to discuss progress and longer-term projects or activities.
• Provide input on methodological work or approaches, assist in designing protocols, and consult on updates to project progress;
• Provide advice to the recipients on specific scientific and analytical issues;
• Organize and participate in webinars with PDs/PIs to monitor progress and facilitate cooperation;
• Monitor progress of the projects and adherence to the strategic goals of the program;
• Track accrual of study participants to ensure proper completion of this essential step;
• Provide administrative management to convening the Steering Committee, organize meetings, and monitor implementation of its guidelines and procedures;
• Stimulate interactions among awardees; and
• Contribute to publications and presentations resulting from the project if appropriate.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist) and be the same person as the Project Scientist.

Areas of Joint Responsibility include:

The NCI Project Scientist and the PD/PI of the Cooperative Agreement awards funded under this initiative will be jointly responsible for participating in initiative-wide and project-related activities and for establishing inter-project collaborations with other awardees under this RFA. In addition to the interactions defined above, the NCI Project Scientists and recipients shall share responsibility for the following activities via a Steering Committee, which will serve as an organizational body for the NCI and awardees.

The Steering Committee will consist of the following voting members:

• Principal investigator(s) of each award;
• Two NCI Project Scientists (Co-Coordinators); and
• A chair of the steering committee, who will be selected at the first meeting. The chair will serve a term of 12 months.

Each recipient will have one vote and based on the actual number of awarded projects, the number of NCI/NIH votes will be adjusted so that the ratio of NCI/NIH votes to Project votes does not exceed 1:3.

The Steering Committee will be organized and administratively managed by the NCI program staff and will meet for at least one annual meeting (either virtually or in-person) during the grant period where all recipients will discuss award-related and program-related issues, including but not limited to progress on proposed specific aims, data collection measures, methodologic work, recruitment/retention goals, data sharing, data deposition, and community-engagement activities. Additional webinar meetings will also be organized by the NCI program staff throughout the award period as needed. At the meeting(s), recipients will work together under the guidance of NCI program staff as a consortium of investigators to advance the objectives and goals of this initiative.

In addition, other NCI Program Officials (as non-voting members) may serve on the committee to help with issues regarding recruitment, follow-up, quality control, protocol adherence, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. The Steering Committee may establish working groups/sub-committees as needed, e.g., to address specific scientific or administrative issues.

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

3. Data Management and Sharing

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

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

4. Reporting

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

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

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]

Michelle Mollica, PhD, MPH, RN, OCN
National Cancer Institute (NCI)
Telephone: 240-276-7621
Email: [email protected]

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.