Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Coordinating Center for Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • May 6, 2021 - Notice of Pre-Application Webinar for RFA-CA-21-031. See Notice NOT-CA-21-078.

Funding Opportunity Announcement (FOA) Number
RFA-CA-21-032
Companion Funding Opportunity
RFA-CA-21-031 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.395, 93.399
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute will support a Coordinating Center (CC) to facilitate coordination across the new Exercise and Nutrition Interventions to Improve Cancer Treatment-related Outcomes awardee sites (see U01 awards supported under companion RFA-CA-21-031). This CC will support three to five anticipated cooperative agreement (U01) project sites focused on the conduct of exercise and medical nutrition clinical trials to improve cancer treatment-related outcomes. The CC’s primary mission will include collaborative scientific contribution and entail administrative and communication responsibilities. The activities and responsibilities include, but are not limited to, fostering collaboration among transdisciplinary scientific teams across U01 research sites, facilitating identification and collection of common data across U01 sites for use in pilot projects, participating in cross U01 site pilot projects and leading data analyses, exploring opportunity for novel data collection, examining common research questions across U01 sites, and providing communication and logistical support for annual in-person meetings of the U01 project sites and other cross-site virtual meetings of U01 investigators. The CC will also develop and execute a platform to monitor progress and facilitate evaluation of the initiative across U01 project sites. The awardee will participate in an Exercise and Nutrition to Improve Cancer Treatment-related Outcomes (ENICTO) cooperative agreement consortium.

Key Dates

Posted Date
May 3, 2021
Open Date (Earliest Submission Date)
June 14, 2021
Letter of Intent Due Date(s)

June 14, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 14, 2021 Not Applicable Not Applicable October 2021 January 2022 April 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Expiration Date
July 15, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute will support a Coordinating Center (CC) to facilitate coordination across the new Exercise and Nutrition Interventions to Improve Cancer Treatment-related Outcomes (ENICTO) awardee sites (see U01 awards supported under companion RFA-CA-21-031). This CC will support three to five anticipated cooperative agreement (U01) project sites focused on the conduct of exercise and medical nutrition clinical trials to improve cancer treatment-related outcomes. The CC’s primary mission will include collaborative scientific contribution and entail administrative and communication responsibilities. The activities and responsibilities include, but are not limited to, fostering collaboration among transdisciplinary scientific teams across U01 research sites, facilitating identification and collection of common data across U01 sites for use in pilot projects, participating in cross U01 site pilot projects, and leading data analyses, exploring opportunity for novel data collection, examining common research questions across U01 sites, and providing communication and logistical support for annual in-person meetings of the U01 project sites and other cross-site virtual meetings of U01 investigators. The CC will also develop and execute a platform to monitor progress and facilitate evaluation of the initiative across U01 project sites. The FOA aims to support precision approaches to exercise and medical nutrition interventions to improve cancer treatment-related outcomes. The CC is expected to comprise multidisciplinary teams of scientist who will support an array of activities across the U01 projects.


Key Terms for this FOA

Body Composition: The quantification of the amount of fat, bone, water, and muscle in the human body.

Cancer Survivor: Any individual diagnosed with cancer from the time of diagnosis until the end of life.

CTCAE: Common Terminology Criteria for Adverse Events.

Exercise: Structured movement for a specific purpose (e.g., improve strength or cardiorespiratory fitness [CRF]) that is characterized by frequency, intensity, time, and type (FITT) criteria and follows exercise-training principles (e.g., overload, progression or specificity principles).

Exercise Dose: The quantification of an exercise exposure by frequency, intensity, time/duration for a specific type of exercise (i.e., dose of an exercise bout), and procedures for implementing and regimenting exercise exposures over time in an exercise program deriving from an exercise prescription inclusive of type, frequency, intensity, duration criteria and exercise principles (i.e., dose of an exercise program in terms of volume, pattern, and progression).

FITT Criteria: Frequency, intensity, time, and type of exercise (FITT) criteria following exercise-training principles (e.g., overload principle) used to establish an exercise prescription.

Medical Nutrition Interventions: Manipulation of the subject's nutritional intake for the purpose of modifying one or more health-related endpoints. This includes both interventions that take place within a clinical setting and those in free-living environments to include a wide variety of nutritional manipulations (e.g., intermittent fasting, ketogenic diets).

Patient-Reported Outcome: Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.

Physical Activity: any voluntary bodily movement produced by skeletal muscles that require energy expenditure that may occur during leisure time, for transport to get to and from places, or as part of a person's work.

Treatment-related Outcomes: any physical, social, or psychological effect that impacts one's well-being that results from cancer treatments, rather than the natural course of the disease. Specifically, this FOA is focused on: dose interruptions, reductions, or delays; related healthcare utilizations (e.g., hospital admissions, length of stay, or emergency department visits); and/or severe adverse events (e.g., CTCAE = 3, or dose-limiting toxicities or organ-specific toxicities) that occur during or in close proximity to cancer treatment for curative or life-extending intent.

Background

Lack of exercise, low physical fitness, obesity, and inadequate nutrition are associated with poor treatment tolerance for cancer survivors, interruptions in treatment, cancer treatment-related toxicities, and longer post-surgical hospital stay. Despite advances in treatment, cancer survivors are at high risk of morbidity and mortality due to their disease, cancer treatment, and frequently worsening fitness and body composition. There is strong evidence that engagement in physical activity and maintenance of healthy weight and diet are associated with reduced morbidity and mortality, and improved quality of life of cancer survivors. Exercise and medical nutrition interventions have been shown to improve fitness and body composition, are generally well tolerated, can be tailored to the individual needs of cancer survivors, and can be delivered concurrently with cancer therapies. However, most exercise and medical nutrition intervention research has focused on cancer prevention or survivorship well past cancer treatment, rather than the period shortly before or during treatment. Additionally, prior interventional studies of cancer survivors largely employed exercise and dietary guidance attuned to general nutrition and physical activity guidelines, but recent literature reviews indicate that benefits may derive from specific medical nutrition and exercise regimens (i.e., prescriptions) that are more refined and targeted to the timing of cancer therapies or tailored to address common possible adverse effects of cancer treatment. Clinical trials are needed to provide evidence for specific exercise and medical nutrition interventions that will improve treatment-related outcomes among cancer survivors and inform their use in clinical settings. The CC will support U01 project sites conducting exercise and medical nutrition clinical trials to improve cancer treatment-related outcomes, and it will engage in collaborative activities with the U01 sites.

Objectives and Responsibilities for this FOA

Because of the requirement for interaction and collaboration across U01 sites, the CC will provide the organizational leadership necessary to facilitate the interactive and integrative functions essential to foster transdisciplinary interaction. The CC has three overarching scientific, communication, and administrative responsibilities. To be responsive, applicants must demonstrate competencies in the areas described in the Objectives of each section below.

I. Scientific Objectives and Responsibilities
Objectives

  1. Develop and implement a platform for U01 sites to report data elements involving exercise, physical activity, medical nutrition, diet, cancer treatment delivery metrics, and cancer treatment-related and patient-reported outcomes across U01 sites.
  2. Develop and implement a platform for U01 sites to report intervention protocol elements and sample population geographic and demographic characteristics.
  3. Devise methods to identify, harmonize, and analyze common data elements across U01 sites.

The successful CC applicant will have demonstrated expertise with analysis of clinical trial data and methodology used in exercise and medical nutrition intervention research and will be able to implement data reporting platforms. In addition, the CC will identify opportunities, by harmonizing and analyzing common data elements, to address research questions that could not be addressed by individual U01 sites.

Responsibilities

Participate as a member of a cooperative agreement Steering Committee: The CC principal investigator (PI), the U01 PIs, and an NCI scientific officer will form a Steering Committee that shall determine cross-site scientific priorities, activities, and use of funds dedicated for cross-site pilot projects. The Steering Committee should work together to maximize shared resources. Details on the composition and functions of the SC are provided in Section VI. Award Administration Information, Terms and Conditions of Cooperative Agreement, “Areas of Joint Responsibility.”

Lead activities to support collection and use of common data: The CC will provide scientific leadership and staff resources towards the identification, standardization, and collection of common data elements across the U01 project sites that, in turn, will enhance data harmonization, analysis, interpretation, and communication of cross-site data pooling and pilot projects. The CC will:

  • Support the process to identify and develop commonalities in methodologically based research questions being explored across U01 sites, compile measurements and protocols for exercise, physical activity, diet, body composition assessments, and biospecimens in use across U01 sites, review relevant literature, and assess the advantages and disadvantages for possible common measures.
  • Create common data entry platforms, will archive data sets for common use, and support common resources that can be shared across each U01 project site.
  • Develop and implement common formats for reports, protocols, and descriptions.
  • Document and archive cross-site data harmonization and pooling procedures and provide necessary technical support (e.g., share and advise on the use of data entry platforms, data algorithms, procedures for sample collections or patient-reported outcomes, or methods to harmonize and describe cancer treatments received by research participants).
  • Provide, in addition to expertise in scientific administration, informatics, exercise science, medical nutrition, and data science, expertise, such as implementation science or cost evaluation, to explore opportunities for novel data capture across U01 sites that may arise as part of participation in the ENICTO consortium but could not be envisioned by individual U01 sites at the time of their application.

Participate in pilot projects and collaboration: Each U01 site and the CC are required within their budget proposal to support cross-site pilot projects. Pilot project activities are in addition to the general functions and responsibilities of the CC. Where possible, pilot projects will be encouraged to involve investigators and/or co-investigators, have a transdisciplinary focus, and use common measures and procedures that allow pooling of data. The CC will be a collaborative scientific partner in these pilot projects and engage in activities including but not limited to:

  • Engaging in project framing, providing data collection, analytic, and scientific expertise such as by suggesting ways cross-site data may be compared or combined to examine detailed questions in specific populations, explore opportunities for novel data collection (e.g., collection of intervention feasibility or cost data);
  • Identifying investigators and coinvestigators across U01 sites with common interests (e.g., patient-reported outcomes related to cancer treatment; exercise testing; medical nutrition); and
  • Supporting communication platforms and scheduling activities for special interest groups that investigators form for collaboration.

Required Expertise
Exercise and nutrition clinical trials: While the CC will not be conducting clinical trials, the CC must have expertise in the self-reported and the physiological and clinical assessments routinely used in the conduct of exercise and nutrition intervention research. A core function of the CC will include the collection and analysis of common data across U01 sites which requires expertise in the methods used to collect and analyze longitudinal data. In some cases, common data could come from opportunities for U01 sites to adopt identical measures. In other instances, expertise to harmonize data involving a shared construct (e.g., exercise capacity and diet quality) but deriving from a different measurement tool or approach (e.g., different exercise and functional tests, and use of different body composition assessment approaches) may be needed. For example, a shared construct, physical activity, will often entail different measures for children and adults due to differences in recall ability. Similarly, prescribed diets may be calorically identical but differ in the prescribed frequency in which they are to be consumed (e.g., time-restricted eating). Exercise volume may be identical across intervention protocols but differ in the way they are prescribed (e.g., exercise at a constant intensity or alternating intensity in exercise bouts). Additionally, since it is anticipated that some U01 trials will incorporate an exercise dosing phase in order to finalize an intervention protocol, the CC should have familiarity with these designs.

Collection and analysis of cancer treatment and clinically related outcome: The CC must have familiarity and expertise in the patient-reported and clinical assessments routinely used in clinical trials conducted in the context of cancer treatment. Self-reported patient outcomes may include measures of psychosocial adjustment as well as cancer-treatment-related adverse events. Clinical assessments may involve functional assessments and bioassays. While individual U01 project will be collecting robust information concerning the type of cancer treatment (e.g., surgery, chemotherapy, and radiation) and its delivery (e.g., planned and delivered dose) and other types of medical care utilization, treatments, and primary and secondary outcomes are expected to differ across sites. The successful CC applicant will have demonstrated expertise and experience to gather cancer treatment information across sites and leverage opportunities for harmonizing and analyzing data across sites.

Collection and analysis of novel data related to implementation and cost evaluation: While the U01 sites will not be conducting study protocol implementation feasibility and cost analyses, there may be an opportunity to address questions related to research translation by collection of data across U01 sites that would not otherwise be possible. CC should have the expertise to identify relevant measures suitable for the ENICTO clinical trials, to assist U01 sites in reporting these data, and lead analyses.

II. Administrative and Communication Objectives and Responsibilities
Objectives

  1. Develop and maintain a website for the ENICTO consortium initiative.
  2. Develop and maintain a system for group communication and documentation of the Steering Committee, cross-U01 site scientific interest group, and pilot project activities.

Responsibilities
The CC will work with NCI and Steering Committee to plan and coordinate annual required in-person meetings of all U01 PIs and to generally support communication and other teleconference or videoconference meetings among cross-site pilot project teams and related cross-site scientific interest groups. The purposes of these meetings are to share scientific information, to assess scientific progress in the field, to identify new research opportunities and pilot projects, to promote inter-initiative collaborations to foster discovery, and to resolve areas of controversy. In addition, the successful applicant for the CC (U24) will demonstrate the capacity to collaborate with the U01 sites and NCI Program Staff to develop an evaluation system that will be integrated into the CC’s design and operations. This system will make it possible to track each project site’s performance and enable NCI to monitor the evaluation of the initiative as a whole. For example, this component includes evaluating the indicators of success such as collaborative linkages and resource sharing arrangements among the project sites, cross-site participation on special interest workgroups, participation on pilot projects and products deriving thereof, and recruitment and retention outcomes. Evaluation variables may include items such as peer-reviewed publications, developed websites, theoretical models within new initiatives, evidence-based diffusion or dissemination strategies, intervention protocols, racial/ethnic and gender diversity, or new collaborations and partnerships.
The CC may engage in the specific activities including, but not limited to:

  • Coordinate and provide logistical and technical support for the required annual in-person meetings among the CC PI, U01 investigators and the NCI;
  • Develop a website and email system for group communication;
  • Arrange all conference calls and/or virtual meetings (e.g., Steering Committee and scientific interest groups or subcommittees formed by the Steering Committee);
  • Prepare and post minutes of conference calls and in-person meetings on the initiative website;
  • Coordinate preparation of scientific publications and dissemination of findings, as is appropriate, from the primary projects and cross-site projects;
  • Develop and implement an evaluation plan for products deriving from the initiative (e.g. tracking pilot projects, presentations and publications, research participant recruitment and retention, and methodologies developed); and
  • Provide reports regarding collaboration and evaluation metrics to the NCI and U01 sites.

Required Expertise
Scientific administration, coordination, and evaluation expertise: Experience with coordination of NIH initiatives involving projects encompassing behavioral intervention and cancer care, coordination and meeting planning, informatics, and website development is required to fulfill the research goals and objectives. Experience and expertise in program evaluation and familiarity with transdisciplinary research are also necessary. The purpose of the evaluation process is to assist NCI in monitoring the performance of the U01 awardees in achieving research goals. Criteria for the evaluation will be developed by NCI and as described in Section VI.

Governance of the ENICTO Consortium

The ENICTO consortium will be governed by an ENICTO Steering Committee (SC). The SC will oversee and coordinate cross-site activities of all awardees supported under RFA-CA-21-031 and the ENICTO Coordinating Center supported under RFA-CA-21-032. Details on the composition and functions of the SC are provided in Section VI. Award Administration Information, Terms and Conditions of Cooperative Agreement, “Areas of Joint Responsibility.”

Evaluation of the Consortium

Awardees will be required to participate in an external evaluation process of the ENICTO consortium coordinated by NCI Program Staff. The purpose of the evaluation process is to monitor and assess the performance of awardees in achieving the goals of this FOA. Criteria for the evaluation part will be developed by NCI Program Staff (as described in Section VI).

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI Division of Cancer Control and Population Sciences intends to commit up to $1 million in FY 2022 to fund one award.
Future year amounts are anticipated to be at the same levels but will ultimately depend on annual appropriations.

Award Budget

Application budgets may not exceed $875,000 in direct costs (excluding subaward F&A costs) per year and must reflect the actual needs of the proposed project

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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. 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 NOT-OD-11-101)

Application must have a different PD/PI and distinct research team than an application submitted in response to RFA-21-031 PD/PI.

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:

Frank M. Perna, Ed.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6782
Email: pernafm@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

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.

Facilities and Other Resources: In addition to standard information, list/document unique and critical resources and/or infrastructure that is available (e.g., unique platforms/technologies/tools, capabilities of institutional information technology systems in terms of handling flows of data that are to be expected, research software expected to be used by ENICTO etc.). If resources listed are shared, specify and document arrangements through which priority and sufficient access will be granted for the purposes of the project. The list in this attachment may include the capacity for data submission and storage, as well as the ability to develop specific criteria for evaluating data quality. Document the ability to implement changes in the systems available as needed to integrate bioinformatics infrastructure across research sites (which may require such elements as a uniform data reporting standard, optimization, integrated data mining, and others).

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Project years must also include $35,000 (in Other Direct Costs) for use in Cooperative Agreement cross-site pilot projects in each year for years 2, 3, 4, and 5. Use of funds for pilot project may not be re-budgeted and shall be determined by the terms of the cooperative agreement as described in Section VI.2.

Costs of participating in meetings. Applicants should budget for the PD/PI and/or alternatively designated representatives (in aggregate, up to 3 members of the research team) to attend annual face-to-face Exercise and Nutrition Interventions to Improve Treatment-related Outcomes investigator meetings.

Due to the complexity of the Exercise and Nutrition Interventions to Improve Treatment-related Outcomes initiative and existence of pilot project funds, it is likely that presenters outside of the initiative may be asked to address the U24 and U01 awardees at annual meetings in each project year. Applicants should be prepared for annual meetings and should budget accordingly (including travel for up to two collaborators, and other necessary related costs, in each project year).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims. Present the overall vision for the proposed ENICTO-CC including the following items:

  • Outline the overarching aims for the ENICTO-CC especially with regard to research coordination and use of common data elements (e.g., such as those arising from exercise and medical nutrition protocols, physiological or functional test results, cancer treatment outcomes, and patient-reported outcomes) that may be expected from exercise and medical nutrition clinical trials in patients initiated before or during cancer treatment.

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

Sub-section A. Background and Significance

  • Overview the rationale of how the proposed research coordination approach will improve the understanding of ENICTO and how it may inform future research and translation into patient care.
  • Where applicable, concisely overview relevant literature concerning how research coordination and particular approaches, especially concerning methods employed in the application, furthered knowledge gained from exercise and/or nutrition behavioral clinical trials, especially those related to cancer treatment.

Sub-section B. Innovation

The cooperative agreement structure and inclusion of pilot project funding in this FOA and the companion RFA-CA-21-031 provides the opportunity to pool data across research sites, possibly collect new data, and to pursue research questions collectively that could not be pursued by individual U01 research sites. Briefly describe how the proposed work maximizes this opportunity.

Sub-section C. Approach

Overview of the Proposed ENICTO-CC. In describing how the Administrative responsibilities and Scientific Research responsibilities are supported, address the following points.

  • Applicant Group. Provide details on collective aspects of the team expertise and capabilities (that are not covered and cannot be covered by individual biosketches). For example, outline the proposed Team structure and explain how each member of the Team contributes to achieving the objectives of the proposed studies. Highlight how the diverse expertise of the Team members leads to synergy in terms of the innovation of which the Team is capable, the flexibility they possess to redirect research when scientific progress warrants it, and their ability to anticipate new directions, based on their individual experience and ability to contribute to a collective effort. If applicable, provide evidence of previous successful collaborations among members of the applicant team.
  • Proficiencies. Without repeating information from individual biosketches, summarize the group’s collective proficiencies and experience in exercise and nutrition clinical trial data analysis projects, cancer patient-reported outcomes, and integration into clinical oncology care. For example, outline the proposed Team structure and explain how each member of the Team contributes to achieving the objectives of the proposed work. Highlight how the diverse expertise of Team members leads to synergy in terms of the innovation of which the Team is capable.
  • Data collection tools and platforms. It is expected that the ENICTO-CC will create platforms for common data elements and tools to harmonize data representing the same constructs (e.g., demographic information, physical activity, fitness, body composition, patient-reported outcome, cancer treatment received, etc.) but that may differ in measure used across sites. Describe approaches to efficiently collect common data elements from research sites and, as is applicable, harmonize measures to the types of data generated. Tools should be targeted for the generation of standardized and well-documented datasets for analysis. Outline approach that can be used for data integration with visualization.
  • Experience. Describe experiences with analysis of data from behavioral intervention trials that informed or may inform translation into clinical care especially with respect to proposed research goals and to generating feasibility and/or cost information. It is expected that the ENICTO-CC will perform statistical analysis of cross ENICTO site data as required for cross-site projects and will provide statistical and analytical confirmation of relevant discoveries and/or data harmonization approaches as is appropriate based on the type of analysis performed and data generated.
  • Where applicable, preliminary data relevant to the proposed methods should be included.

Sub-section D. Pilot Projects

  • List the areas/possible directions for which pilot studies are anticipated that make use of collective data or that leverage the opportunity for novel data collection and analysis across ENICTO research sites.
  • Briefly describe and justify these choices by explaining why additional efforts in these areas/directions might be useful. Indicate how the concepts for such studies will be formulated. (No pilot studies are to be proposed in the applications submitted in response to this FOA).

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 address a Data Sharing Plan.
  • Data Sharing Plan should be consistent with accomplishing the goals of the ENICTO in cooperative agreement consortium as further described in Section VI.2. Specifically,
    • Data Sharing Plan should acknowledge that the ENICTO-U24 awardee will be required to accommodate data, as identified by the ENICTO Steering Committee as a common data element, to be upload from ENICTO-U01 sites and upon request from NCI Program staff.
    • Data Sharing Plan should acknowledge that the ENICTO_U24 awardee will be required to make available data sets constructed for activities and projects approved by the ENICTO Steering Committee.
    • Data Sharing Plan should acknowledge that the ENICTO_U24 awardee will be required to make available all of their data from ENICTO Pilot Projects and collaborative projects, as approved by the ENICTO Steering Committee, to the ENICTO-U01 awardees.
    • Data Sharing Plan should acknowledge that the ENICTO_U24 awardee will be required to make available algorithms produced for harmonization, standardization, and analyses of common data elements, and any new data deriving from ENICTO pilot projects, will be released and shared.
  • Sharing Additional Resources: Consistent with achieving the goals of this program, all resources generated by the ENICTO awardees (e.g., standards and SOPs) will promptly become available through an ENICTO Coordinating Center resource. It is anticipated that other distribution avenues will be made available by the NCI if determined to be necessary.
  • Note that the NCI Program Staff may negotiate modifications to these plans prior to funding.
  • ENICTO Intellectual Property Policy: Consistent with achieving the goals of this program and maximizing the benefit of all research funded as part of the ENICTO program for the improvement of public health through discoveries of the scientific community, ENICTO Data Sharing and Data Release policies expect a broad freedom-to-operate for all users of ENICTO data (e.g., by rapidly making data and results available in the public domain).
     
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number 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 the NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

In determining the merit of applications, reviewers will emphasize the applicants' capabilities and plans in terms of the stated scientific, technological, and organizational requirements.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Coordinating Center address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this FOA

How well will the proposed activities facilitate the interactive and integrative functions essential for the ENICTO program to advance knowledge of exercise and nutrition intervention to improve cancer treatment-related outcomes, especially knowledge that may inform translation to clinical care? How strong is the rationale that the ENICTO-CC, as proposed, will contribute meaningfully to scientific, communication, and administrative objectives?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing such research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA

How innovative is the application in terms of processing and integrating anticipated common data to arise from exercise and nutrition clinical trials in the context of cancer treatment? How innovative is the application in terms of leveraging the opportunity for novel data collection and collective pursuit of research questions?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

Specific to this FOA

How well does the applicant's plan for the collection, standardization, and harmonization, and sharing of common data elements address the ENICTO scientific goals? How strong is the potential of the applicants for team science approaches to developing and facilitating pilot project research studies? To what degree will the proposed ENICTO-CC be able to participate in inter- and trans-disciplinary team-based research efforts, including potential for interactions with investigators from other ENICTO-U01 sites and NCI staff members?

Environment

Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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 National Cancer Advisory Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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 awardees, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • Defining goals and objectives; determining research approaches and procedures; developing evaluation metrics; collecting and managing data; analyzing, interpreting, and publishing results;
  • Developing and implementing strategies for ENICTO Steering Committee-approved activities for the collection and standardization of common data elements and procedures;
  • Developing a manual for documentation of all operations, common measures, evaluation metrics, and ENICTO pilot projects and activities;
  • Ensuring that up-to-date detailed descriptions of outcomes will be made publicly available in the appropriate scientific outlets, project website, group presentations or publications in a timely manner;
  • Attending one in-person meeting a year along with key co-investigators and participating in regular (approximately monthly and additional as needed) conference calls;
  • Coordinating all logistical, technical, and accommodations to support annual meetings, arranging for meals and facilitating activities during the meeting, and developing the agendas of the annual meeting and specific special interest group meetings and Steering Committee conference calls;
  • Coordinating synthesis papers and group responses bringing together disparate information to inform the scientific community and the general public;
  • Formulating research questions and prioritizing, and coordinating work related to cross-site pilot projects and other collaborative activities;
  • Fielding outside requests and working with the Steering Committee to determine priorities;
  • Coordinating conference calls and communication within the Steering Committee and specific scientific interest groups;
  • Providing an annual progress report and other information on study progress as might be needed;
  • Abiding by the Resource Sharing Plan, as appropriate, as well as specific procedures to be developed by the ENICTO Steering Committee;
  • Participating in program-wide activities, such as presentations at national meetings and conferences;
  • Coordinating the preparation of the annual progress reports by the individual PD/PIs; and
  • Coordinating the preparation of materials for use by the NCI for ENICTO program evaluation.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current 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 Scientist(s), will coordinate in a centralized fashion various activities of the awardees. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to, the following aspects:

  • NCI Project Scientists may serve on cross-site special scientific interest groups and pilot projects;
  • Administratively manage the Steering Committee and monitor implementation of its guidelines and procedures;
  • Organize and conduct regular meetings to share progress by teleconference and/or videoconference as needed amongst the ENICTO awardees, in addition to an annual face-to-face meeting of all awardees;
  • Contribute scientifically and participate in analyses of cross-site pilot project data and publication efforts;
  • Assist the awardees by sharing information about a wide range of NCI and NIH resources and/or serve as a conduit to the potential utility and access to these resources;
  • Provide advice on other specific scientific and technical issues as needed by the awardees;
  • Serve as liaisons to other NCI scientific staff members if additional expertise or resources are needed;
  • Provide information about possible collaborative opportunities with relevant NCI sponsored networks, and other relevant government and non-governmental organizations doing related work;
  • Facilitate collaborative research efforts that can involve awardee as well as investigators from other NCI-related initiatives;
  • Monitor the progress of the ENICTO awardees and make recommendations on cross-site project directions and oversight of allocations of U01 funds set aside for pilot projects per NCI policy; and
  • Conduct periodic site visits of awardees and take other actions as needed.

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 Scientists and the PD/PI of the Cooperative Agreement awards funded under this initiative will be jointly responsible for participating in initiative-wide activities and for establishing cross-site project collaborations. In addition to the interactions defined above, the NCI Project Scientists and awardees shall share responsibility for the following activities via an Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes Cooperative Agreement Steering Committee, which will serve as an organizational body for the NCI and awardees.

The ENICTO Steering Committee will serve as the initiative’s main governing board of the ENICTO program. The Committee will be jointly established by the PDs/PIs from each ENICTO-U01 awardee site, the PD/PI from the companion ENICTO-U24 Coordinating Center (PD/PI), and NCI designated Program Staff members. The ENICTO Steering Committee will provide strategic coordination for the cross-site activities.

Details on the composition, functions, and responsibilities of the ENICTO Steering Committee are following.

Voting members of the ENICTO Steering Committee will include:

  • One representative from each ENICTO-U01 awardee site;
  • One representative from the ENICTO-U24 Coordinating Center;
  • One representative from the NCI.

Non-Voting Members:

  • The ENICTO Steering Committee may decide to add non-voting members as needed, e.g., representatives from NCI-supported research resources, scientific experts and/or patient advocates.

The ENICTO Steering Committee will formulate strategic decisions and policies for consortium-wide activities. The ENICTO awardees will be required to accept and implement these decisions and policies to the extent consistent with applicable grant regulations.

  • All Steering Committee decisions and recommendations that require voting will be based on a majority vote;
  • The chair of the steering committee will be elected by the members and have a term of one year but can serve consecutive terms; and

The responsibilities of the Steering Committee will include the following activities:

  • Steering Committee will formulate strategic decisions and policies for consortium-wide activities and   procedures;
  • The Steering Committee may establish subcommittees to support specific purposes (e.g., scientific interest groups related to exercise, nutrition, and translational science; data harmonization; or pilot project publication committee).
  • Providing guidance to subcommittees to assist them in interpreting and adhering to Steering Committee established policies and procedures of the consortium;
  • Developing policies andprocedures across the consortium and also, for projects seeking to use designated pilot project funds;
  • Formulating policies and procedures for data collection and harmonization as well as for common data elements;
  • Coordinating communication between the awardee-site teams, possible subcommittees, and cross-site pilot project teams;
  • Setting Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes Cooperative Agreement publication policies and establishing recommendations/guidelines for elements to be included in publications reporting on cross-site projects and publications deriving from pilot project funds within the award;
  • Building consensus and coordinating the critical evaluation of disparate results;
  • Setting (in consultation with the other PD/PIs) the publication agenda and schedule;
  • Determining the location of the annual meetings and coordinating the organization of these meetings; and
  • Setting policies and procedures that may arise in the consortium for the implementation of professional enhancement opportunities for junior investigators.

Pilot Projects and Collaborative Activities

The ENICTO-U01 awardees, ENICTO Coordinating Center, and NCI project scientists will be jointly responsible for participating in initiative-wide activities and for establishing cross-site project collaborations. These activities may involve PIs and co-investigators across ENICTO awardee sites and include, but are not limited to, the following:

  • Serving as a member of an appropriate ENICTO cross-site scientific interest group;
  • Participating in collaborative pilot projects approved by the Steering Committee, sharing information, as appropriate, about intervention protocols and assumptions at working group meetings; and
  • Consulting on strategies for participant recruitment and retention and providing information for dietary and exercise protocols and calibration that may benefit the ENICTO in whole and be useful to the wider scientific community.

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 awardee. This special dispute resolution procedure does not alter the awardee'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. Reporting

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. 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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Frank M. Perna, Ed.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6782
Email: pernafm@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dm437a@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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