Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity announcement (NOFO) aims to support the initiation and building of the next generation of population-based cancer epidemiology cohorts to address scientific knowledge gaps in cancer etiology and cancer survivorship across various populations, including underserved and understudied populations. It aims to enable prospective cancer epidemiologic research that can identify environmental, genomic, lifestyle, clinical, socio-cultural determinants, and other factors that affect cancer risk (e.g., incidence) and survivor-related outcomes (e.g., morbidity, mortality, recurrence, secondary cancer, and quality of life). Proposed research cohorts should: (i) complement current existing cohorts and address resource and scientific gaps; (ii) enable prospective investigations of new scientific questions; and (iii) foster incorporation and adaptation of new technologies and approaches to achieve goals and objectives. Specifically, applicants should propose aims that lay the foundation and structure for new sustainable cancer epidemiology cohorts and outline science-driven goals, propose methodological work relevant to the goals, and incorporate hypothesis-driven short-term research question(s) with specific milestones achievable within the 5-year grant period.

Key Definitions for this NOFO

Cancer Epidemiology Cohort: An observational population study in which a group of people with a set of characteristics or exposures are prospectively followed over time. Etiology cohorts are followed for the incidence of new cancers. Survivor cohorts follow cancer survivors for cancer-related outcomes. Prospective cohort studies recruit participants and assess exposures before the development of the outcomes of interest (i.e., cancer outcomes).

Understudied populations: Understudied populations are defined as a specific group who may or may not be medically underserved or socially disadvantaged but whose data on cancer health risks and outcomes are currently limited and thus insufficient to inform evidence-based cancer control, prevention, and intervention guidelines. The dearth of research and information for these groups underscores the urgency to improve our available data and knowledge regarding cancer risks and outcomes within these understudied populations.

Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing health coverage and basic health care services. A full description can be found at https://www.nimhd.nih.gov/about/overview/.

Community partners: Community partners should represent the population being recruited for the study. Partners may be representatives of advocacy groups, community centers, support, or research organizations; community or religious leaders; liaisons to racial/ethnic groups (e.g., Latino, Asian American, Native American, or African American populations); community health workers, etc.

Background

The United States (U.S.) is rapidly evolving with a changing environmental and demographic landscape that will differ from the one of previous decades. Climate change, air and light pollution, chemicals, novel behavioral factors (e.g., screen-time, cannabis use), new treatment/medications, and sociocultural-related factors present a few examples selected to illustrate a different environmental landscape from previous decades. Likewise, cancer survivors are living longer, due in part to advances in detection and treatment, but may face physical, mental, social, and financial toxicities resulting from their care. Moreover, the U.S. is becoming more demographically diverse. The 2020 US Census results showed escalating growth for non-white groups such as Asians and Hispanics when compared to the previous decade. Collectively, this changing landscape will impact cancer-related burden which, in turn, will have significant future implications and challenges on cancer control and prevention. The ensuing challenges will require innovative research buttressed by appropriate resources to meet the changing needs of an evolving multi-racial/ethnic nation.

Prospective cohort study design is an optimal scientific method for assessing the effects of suspected risk factors in human populations. It serves a critical role in illuminating the etiologic role of environmental, lifestyle, and genetic determinants for cancer-related risk and outcomes. As such, cancer epidemiology cohorts are fundamental to cancer control and prevention, as they can provide insights that inform interventions to decrease cancer incidence, morbidity, and mortality in humans. Future prospective epidemiology cohort studies, therefore, need to be able to examine the unique cancer burden associated with emerging/novel exposures, incorporate genomic factors, and examine the intersectionality of multiple factors to assess cancer risk and survivorship outcomes, and translate findings to improve the health outcomes for all population groups, with deliberate inclusion of understudied populations.

Research Objectives and Requirements for this NOFO

This proposed NOFO will provide funding to assemble the framework, structure, and operational foundation to enable the creation of a new prospective cohort study that would advance our understanding of cancer-related risk and survivorship of healthy populations and cancer survivors, respectively. Applicants should address scientific gaps and expand the heterogeneity of population-based research studies such as (i) representation of study populations (racial/ethnic, geographical, and beyond); (ii) relevant individual-level data, e.g., heritage, country of origin, unique environmental exposures (e.g., persistent organic pollutants and other chemicals, pesticides, infectious agents, water quality), genomic, and lifestyle/behavioral factors (e.g., cultural dietary patterns, sleep factors, use of emerging tobacco products); (iii) data on sociocultural measures (e.g., socioeconomic position, acculturation, assimilation, stress markers) critical to a deeper understanding of their multilevel impact on cancer risk and survivorship; (iv) information on survivor-related factors (e.g., clinical factors and treatment-associated outcomes); and (v) access to and quality of healthcare with cancer prevention, screening, and treatment (e.g., cancer-care delivery systems, financial burden and resources, and employment).

Expectations and Requirements for this NOFO

Applicants responding to this NOFO are expected to include the following elements:

• Scientific justification of the research gap to be addressed in both exposures and outcomes (See Cancer outcomes below).For survivor cohorts, the exposures could be the cancer site or specific survivor-related exposures and endpoints must be justified.
• This NOFO intends to fund new cancer epidemiology cohorts. Applicants are encouraged to review existing cohorts (e.g. those listed in the Cancer Epidemiology Descriptive Cohort Database (CEDCD) to avoid overlap.
• Justification of the study population and sample size (including, if applicable, appropriate considerations of statistical precision for future subgroup analyses) as driven by the proposed science.
• Accrual of study population must be completed by year 5 of a 5-year grant period.
• Demonstration of innovation and novelty in addressing proposed research questions.
• Description of the sustainability and preservation of cohort resources that extend beyond the life of the award.
• Detailed data/resource sharing plans that are consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles for Resource Sharing Plans as provided in SF 424 Application Guide. Data collected under support from this NOFO are required to be submitted to an NIH designated repository. The NCI-approved data sharing plan will become a term and condition of award. The data sharing plan must include details as outlined below:
  • The repository where the data generated under support from this NOFO will be deposited, details how to access the data, and limitations (if any) for use of the data;
  • Timely data and resource sharing after each wave of data collection;
  • Informed consent for the sharing and deposition of data into NIH-designated repository when applicable; and
  • A mutually agreed upon letter of agreement for the data/resource sharing plan from the parent institution must be provided prior to award.

Cancer Outcomes: Cancer outcomes must be validated through linkage to population-based cancer registries and/or medical records or pathology reports.

Applicants should propose specific aims to align with the following:

Methodological Studies

Methodological efforts are practical and important to determine the cohort operational structure, obtain critical baseline data, and develop key infrastructure critical to establishing and sustaining a new cohort. As such, methodologic work focused on logistical and practical details such as (i) approaches to engage, recruit, and retain study participants; (ii) optimal and novel methods to collect accurate exposure and individual-level data; and (iii) methods for biospecimen collection and plan for assessment of stability of long-term storage when appropriate.

Types of feasibility study that would be considered appropriate for this NOFO include, but not limited to:

• ascertain the most appropriate and efficient methods to engage, recruit, and retain a specific population group (e.g. understudied and/or underserved populations);
• assess innovative approach to enhance participant engagement or optimize data access and sharing;
• test novel methods and strategies for data and/or specimen measurement, collection, and/or storage;
• assess effective strategies for biospecimen ascertainment across different facilities (e.g., biobanks, hospitals, commercial labs);
• integrate or link to existing databases to obtain and/or augment non-traditional information (e.g., administrative, socioeconomic position) relevant to cancer control and prevention; and/or
• test measures, data abstraction, or data linkage strategies related to healthcare delivery including, but not limited to, cancer caregiving, financial hardship, telehealth, coordination of care, and access to preventive cancer care and post-diagnosis follow-up care, utilization, and health outcomes;
• assess or test innovate approaches to collect information related to sociocultural, behavioral, lifestyle, disparities and equity, and/or health outcomes across the cancer continuum; or
• test methods to capture cancer recurrences and/or subsequent primary cancers in cancer survivors.

Research Outcomes

Exposures have variable associated latency periods, which will influence the short- and long-term goals of the proposed studies. Applicants should consider research questions that could be addressed in the short-term including assessing validated biomarkers of intermediate risk, behavioral outcomes, or healthcare utilization outcomes. A variety of relevant research may be addressed in the short term related to topics such as exposure assessments, mechanisms of carcinogenesis, association of exposures with intermediate cancer outcomes, genomic studies of diverse populations and cancer risk, exposures, or progression (e.g., using survivor cohorts for cancer cases and other cohorts for controls; using a case-cohort or case-control design leveraging cancer registries for identifying and recruiting cancer cases), socio-cultural and behavioral outcomes, and barriers to the delivery of optimum healthcare.

Community Engagement

The bi-directional partnership between the research scientists and the community partners is critical to incorporate and integrate respective unique strengths and perspectives to inform research priorities. There are also needs for awareness of local culture and belief systems. As such, community engagement activities designed to inform research, enhance recruitment and retention efforts, and disseminate results must be incorporated into the proposed application. Moreover, applicants are strongly encouraged to take advantage of available resources, whenever feasible and applicable, such as those supported by the NCI Center for Cancer Health Equity (CCHE):

• National Outreach Network (NON) and/or
• The Partnerships to Advance Cancer Health Equity (PACHE).

Applicants must provide detailed plans for direct community engagement, in which community partners are incorporated throughout the process. Applicants should provide details for community engagement including:

• Plans to establish a community advisory board with a broad and diverse representation of community-based organizations and key racial/ethnic minority community leaders as relevant to the study population, and multidisciplinary members
• Plans to leverage and/or establish new partnerships with community-based organizations and community partners
• Plans of engaging with the community and study participants using current state-of-the-art approaches, including such aspects as:
  • how planned methods of engagement will be culturally sensitive and appropriate for the population of focus; and
  • community-based participatory research approaches, as applicable for specific research proposal and populations, in which communities are treated as partners with research institutions.
• Plans to communicate to the community and study population information about relevant resources, progress and outcomes such as:
  • summary of health information and resources used in the study;
  • ongoing study updates;
  • aggregated results when available; and/or
  • lay abstracts of study results and publications as appropriate.

Additional Requirements

• Create and maintain an active cohort’s website with relevant study population’s details (current age and vital status) and information on data sharing/access;
• Deposit data to an NIH data repository or a NIH-approved public controlled access data repository, when appropriate;
• Submit descriptive cohort data to the Cancer Epidemiology Descriptive Cohort Database (CEDCD) when requested;
• Evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources for the collection, processing, and storage of biospecimens, if applicable and appropriate;
• Include common use data elements and share protocols for the collection of data and/or biological specimens, as appropriate scientifically; and
• Attend annual meeting(s) at NIH/NCI during the award period design to facilitate exchange of knowledge and foster interactions with other cancer epidemiology cohorts. Additional attendance to webinar meetings may be required throughout the award period.

Applicants are encouraged, where appropriate, to incorporate data through linkages to existing databases with relevant exposure, administrative, and health-related data. For example, linkages to state cancer registries through the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) funded by NCI. Other resources such as Human Health Exposure Analysis Resource (HHEAR) co-funded by NCI, can enable cost-effective approaches to both exposure assessment. Population-based cancer registries (Surveillance, Epidemiology, and End Results Program and State Cancer Registries) also provide frameworks for identifying and recruiting cancer cases.

Non-responsive Applications

Applications that propose any of the following will be deemed non-responsive and will not be reviewed, including those that:

• Are not limited to human populations;
• Does not incorporate a longitudinal study design;
• Continue support to or research solely from an established cohort (defined as those with advanced or completed study enrollment);
• Use primarily secondary data from existing cohort data;
• Do not collect validated cancer outcomes;
• Include foreign components (e.g., countries or exposures) that do not reflect direct relevance to U.S. populations;
• Have data and/or resource sharing plans that do not comply with NIH policy and follow FAIR principles (https://www.go-fair.org/fair-principles).

NOTE: Applicants to this NOFO are strongly encouraged to attend a planned NCI-sponsored pre-application webinar prior to the first due date. For subsequent due dates, applicants will be able to access the recording of the pre-application webinar on the Epidemiology and Genomics Research Program’s website. Applicants should review relevant due dates on the website and contact NCI staff as soon as possible in the development of the application to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this NOFO.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations).

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

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

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

Applicant Organizations

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

• 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 registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Tram Kim Lam, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-6970
Email: [email protected]

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in community-based participatory research, clinical trial education and outreach, referral-to-care, health services or healthcare delivery research, multilevel interventions, experimental or quasi-experimental designs, and implementation science. Research personnel are also expected to have a track record of conducting studies with multiple stakeholder groups involved in healthcare delivery.

R&R or Modular Budget

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

Any individual designated as a PD/PI must commit a minimum of 1.8 person-months effort per year to the project (MPIs must commit a minimum of 1.2 person-months per NCI policy). The PD/PI person-months effort cannot be reduced in later years of the award.

Applications should budget for at least one key personnel to attend the annual Programmatic Meeting for each year of a grant period. The Meeting may take place at an NIH location in Maryland and may overlap the NCI Cohort Consortium's annual meeting.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: All applicants must include the aims that address the main requirements (See Part II.Section 1).

Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.

Sub-section A. Background and Significance

Define, justify, and explain the rationale for the proposed study population and exposure of interest and the selection of the understudied population(s) focus of the project. Provide the research gaps the proposed cohort will address, including how the proposed project will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States?

Sub-section B. Preliminary Data

Though preliminary data (including findings to support proposed approaches) are not required, if limited preliminary data are provided, they will be evaluated. In lieu of preliminary data, applicants may provide the underlying logic or rationale for pursuing the project in the manner proposed. Summarize what is believed to be the major challenges and described alternative approaches that may need to be pursued.

Sub-section C. Short-term and Long-term Research Outcomes

Provide and outline the broad research agenda that the proposed cohort would pursue, including specific long-term research questions. Provide specific short-term research questions and outcomes that are achievable within the grant period.

Sub-section D. Approach

Describe methods/approaches that will be used to accomplish proposed Specific Aims;

• Describe the epidemiological information and data that will be collected.
• Describe the appropriateness of the proposed study design.
• Describe the recruitment and retention approach(es) that will be used. Include a  description of community engagement to optimize recruitment and retention of study participants.
• Describe proposed measures of relevant exposures and the technology/approaches used, when possible highlight the innovation, for data collection and storage as appropriate.
• Describe the analytic plan, including calculations for sample size and power analyses for all aims, and including subgroups, as appropriate.

Sub-section E: Data Sharing and Dissemination

Applicants must provide a detailed plan for the facilitation of data and resource sharing after each wave of data collection. The data/resource sharing plans must be consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/). Instructions for Resource Sharing Plan is provided in SF424 Application Guide. Describe the management and decision-making process that promotes data sharing and timeline for sharing, the repository where the data will be located, process for accessing data, any limitations, etc. The plan should include steps for creating standard operating procedures, accessibility requirements, and review process for granting access to the research community, and dissemination of that information.

Letters of Support: Applicants must include letters of support from collaborating entities (e.g., community partners, community-based organizations, etc.).

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 that are requested for any one year, must address a Data Sharing Plan.
• Applicants must propose a detailed data sharing plan that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) for each wave of data collection.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year must address a Data Sharing Plan.
• Applicants must propose a detailed data sharing plan that addresses rapid data sharing with the community, includes informed consent to permit data deposition/sharing to an NIH-recommended repository, and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) for each wave of data collection.

Other Plan(s): 

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Organizations

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

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

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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

 Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. For more information, please see https://epi.grants.cancer.gov/funding/large-grant-applications/.

Furthermore, applicants requesting $700,000 or more in direct costs in any year will be required to participate in a pre-submission consultation meeting with Program Staff at least 12 weeks prior to receipt date to ensure the scope of the application is appropriate to basic maintenance for existing cohorts to serve as a resource for research according to NIH data sharing policies. Additional information, including contact information and materials required, is outlined on https://epi.grants.cancer.gov/funding/large-grant-applications/. Applicants should contact NCI early enough to ensure the meeting will occur at least 12 weeks prior to submission. Failure to comply will result in the application being deemed non-responsive to the intent of the PAR.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Review Criteria

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

Factor 1: Importance of the Research

Significance

• Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
• Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g. prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

• Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
• Evaluate whether the proposed work applies novel concepts, methods or technologies, or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Specific for this NOFO:

• Evaluate whether the application describes how the proposed cancer epidemiology cohort and study population (e.g., inclusion of understudied populations) address specific scientific gaps relevant to cancer etiology and survivorship
• Evaluate whether the application describes how the proposed project will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States
• Evaluate whether the application proposes novel approaches to improve measurement of exposures and/or representation of populations

Factor 2. Rigor and Feasibility

Approach

• Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

• Evaluate the potential to produce unbiased, reproducible, robust data.
• Evaluate the rigor of experimental design and whether appropriate controls are in place.
• Evaluate whether the sample size is sufficient and well-justified.
• Assess the quality of the plans for analysis, interpretation, and reporting of results.
• Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
• For applications involving human subjects or vertebrate animals, also evaluate:
  • the rigor of the intervention or study manipulation (if applicable to the study design).
  • whether outcome variables are justified.
  • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
  • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
• For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

• Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
• For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex or gender categories.
• For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Specific for this NOFO:

• Evaluate how well the approach addresses both the proposed short-term and long-term research outcomes.
• Evaluate how well the proposed cohort's scale and planned data/biospecimen collections support the research aims of the study.
• Evaluate how appropriate are the plans for data and/or biospecimen collection and storage.
• Evaluate the clarity, feasibility, and comprehensiveness of the plan to monitor recruitment progress and ensure future retention.
• Evaluate how effective the approach to promote the dissemination of cohort-related assets to the broader scientific community.

Factor 3. Expertise and Resources

Investigator(s)

• Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

• Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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.

Vertebrate Animals

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

Resubmissions

As applicable, evaluate the full application as now presented.

Renewals

As applicable, evaluate the progress made in the last funding period.

Revisions

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

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.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

Successful recipients under this NOFO agree that:

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

        1) ongoing and consistent access to HHS owned or operated information or operational technology systems; and 

        2) receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

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

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

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

The PD(s)/PI(s) will have the 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 in the Cohort Program Steering Committee;
• Attend annual meetings, be held either virtually and/or in-person at 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.

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:

• Facilitate collaborations between the awardees 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 cohort’s 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 awardees 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 Cohort Program 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 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:

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 cohort-related activities and for establishing inter-project collaborations with other awardees of cancer epidemiology cohorts. In addition to the interactions defined above, the NCI Project Scientists and awardees shall share responsibility for the following activities via a Cohort Program Steering Committee, which will serve as a non-voting organizational body for the NCI and awardees.

The Cohort Program Steering Committee will consist of:

• Principal investigator(s) of each award;
• Two NCI Project Scientists (Cohort Co-Coordinators); and
• One NCI Program Director assigned to the awarded grant.

The Cohort Program 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 awardees 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), awardees will work together under the guidance of NCI program staff as a consortium of investigators to advance the objectives and goals of this initiative.

The NCI Project staff and awarded PIs will serve on the Cohort Program Steering Committee. In addition, other NCI Program Officials 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 Cohort Program 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 recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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

4. Reporting

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

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

Section VII. Agency Contacts

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

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

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

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

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

Tram Kim Lam, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-6970
Email: [email protected]

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

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699 
Email: [email protected]

Section VIII. Other Information

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

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