It is critical that applicants follow 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 the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative established to accelerate cancer research. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): the Implementation of Integrated and Evidenced-based Symptom Management Throughout the Cancer Trajectory. The purpose of this specific FOA is to promote research on the implementation and evaluation of comprehensive symptom management systems for use in cancer care delivery through a Research Consortium. This research will provide new insights and valuable evidence that can be used to guide efforts on a nation-wide basis to improve symptom control for cancer patients during treatment and survivorship.

The consortium will consist of a Coordinating Center (to be supported by this U24 FOA) and Research Centers (to be funded under a companion UM1 FOA, RFA-CA-17-042).

The Coordinating Center is expected to:

(1) Provide oversight and coordination of the Research Centers and the Steering Committee,

(2) Ensure standardized, uniform, interoperable data collection across the Research Centers,

(3) Establish processes for pooled analyses.

The Coordinating Center is expected to interact with the Research Centers and provide oversight and management of collaborative activities within the entire consortium. Collaborative activities will be supported scientifically and coordinated administratively and logistically by the Coordinating Center.

Research Centers are responsible for the deployment and evaluation of the symptom assessment and management system using implementation science approaches.

NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer research in 5 years, now called the Beau Biden Cancer MoonshotSM Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for symptom management. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.

Need for improved symptom management for cancer patients in healthcare delivery settings. The symptom burden experienced by people with cancer is considerable. Cancer and its treatments produce deleterious symptoms that can persist long after treatment is completed and disease is eradicated. Across disease stages and phases of care, approximately 33% of cancer patients report three or more co-occurring symptoms (e.g., pain, fatigue) that they rate moderate to severe. Poorly controlled symptoms negatively affect health-related quality of life and functional status, and can lead to costly visits to emergency departments, often resulting in hospitalization. Adverse symptoms can lead to delays, in or discontinuation of, cancer treatment. Such disruptions may decrease treatment effectiveness and increase risk for recurrence and death. Adherence problems due to poor symptom control are especially salient among minority and medically underserved cancer patients. Finally, negative effects of treatment have been found to increase the likelihood that patients will not return to work, even if they are disease-free, and impair the ability to work among those who do return.

Patient-Reported outcomes (PROs). The importance of directly capturing the perspective of patients on their own health status and recognition that patients are an essential source of information about their symptom experience and its impact on their functioning have become a major focus of research. To better assess and manage cancer patient symptoms, there has been growing interest in the use of patient-reported outcomes (PROs) to enable standardized symptom assessment. PROs have been shown to be valid and reliable tools for assessing symptoms and are being used increasingly as outcomes in clinical trials. Given this increased uptake in clinical research settings, their use in applied clinical settings has become easier and more appealing. Research demonstrates that oncology care providers consider PRO data to be clinically useful and that collection of PROs as part of clinical care is generally feasible and acceptable to patients. To support their collection, electronic systems have been developed and are in use at several major cancer centers for patient self-reporting of symptoms using established PRO assessment tools. Advantages of electronic systems over paper-and-pencil approaches include the ease of administration and scoring, reduced patient burden (e.g., via computer adaptive testing), and the capability of integrating findings into electronic health record (EHR) systems and existing workflows. However, many of the systems for symptom data capture are idiosyncratic, rarely interoperable, and generally do not provide evidence-based symptom management recommendations in response to symptom reports. Thus, there is a substantial need for systematic, uniform data capture and presentation across clinical settings. In addition, research is needed on the best approaches to streamline PRO data collection and use these data to aid in patient-provider communication, decision-making, and care-coordination across practice settings (e.g., between primary and specialty care practices and among specialty care practices).

Clinical use of PROs. Going beyond feasibility and acceptability, results of controlled studies demonstrate the benefits of collection of PRO data and their delivery to cancer care providers. Clinical use of PROs has been shown repeatedly to improve patient-provider communication about symptoms and individual studies have demonstrated improved symptom control, increased use of supportive care measures, and greater patient satisfaction. The cumulative evidence suggests that effects are likely to be enhanced if clinicians and patients are provided with clear guidance on how to respond to symptom reports. This conclusion is supported by evidence showing that improvements in symptom control are associated with increased adherence to evidence-based guidelines for symptom management. Accordingly, there is an emerging consensus that development and adoption of integrated symptom assessment and management systems represent the most effective way to use PROs to improve symptom control.

Overview. The focus of the Research Consortium supported by this FOA is to use implementation science approaches to accelerate adoption of integrated systems that collect patient-reported symptom data and use these data to trigger a clinical response consistent with evidence-based guidelines. Implementation science approaches to be proposed for this FOA must be systematically planned with a goal to accomplish sustaining changes in clinical practice. This FOA will fund one Coordinating Center to coordinate and support the efforts of the Research Centers funded under a parallel announcement. Because complex, multilevel data will be collected and acted upon from multiple clinical practices for analysis and evaluation, close coordination and efficient lines of communication are needed between the Coordinating Center and the Research Centers. Coordinating Center applicants must familiarize themselves with the UM1 FOA and all the detailed requirements for UM1 studies.

The Main Responsibilities of the Coordinating Center

The Coordinating Center is expected to be responsible for the following activities:

1. Consortium Coordination

• Provide oversight and coordination of the Research Centers and the Steering Committee (these include logistical and administrative assistance including organizing the Steering committee, and arranging Steering Committee meetings and conference calls for the Consortium);
• Develop and maintain formal Consortium documents, including Manuals of Operations and other procedure manuals
• Consolidate Consortium implementation strategies and dissemination materials; and
• Provide other operational support for the Consortium, as needed.

2. Ensure standardized, harmonized data collection across the Research Centers

• Develop procedures to ensure data quality and completeness
• Facilitate the use of common data elements across the Research Centers when there are overlapping topics being assessed (e.g., for data collection of specific symptoms such as pain and fatigue)
• Provide technical and intellectual oversight for data sharing within the Consortium, including the development of combined datasets

3. Establish processes for pooled analyses

• Capacity for data storage and security for combined datasets
• Develop and maintain an integrated research database for all Consortium data
• Develop analytic plans for analyses across Research Centers
• Coordinate the processes for analysis of combined data across all investigators

The Coordinating Center is expected to interact extensively with the Research Centers and provide oversight and management of collaborative activities within the entire consortium. Collaborative activities will be supported scientifically and coordinated administratively and logistically by the Coordinating Center. Expertise is expected to include experience in network coordination, administration of research consortia, management of clinical data and the development of harmonized datasets, bioinformatics, implementation science, and statistical analysis of medical and patient-reported data.

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

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

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)

Governments

• State Governments
• County Governments
• City or Township Governments
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

Investigators designated as PDs/PIs on applications for the Research Centers (UM1) submitted in response to RFA-CA_17-043 are not eligible to serve as PDs/PIs on applications submitted in response to this FOA.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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).

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Ashley Wilder Smith, PhD, MPH
Telephone: 240-276-6714
Fax: 240-276-7906
Email: smithas@mail.nih.gov

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

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

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

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

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

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

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

Any individual designated as PD/PI must commit a minimum of 1.2 person-months effort per year to the U24 award. The commitment cannot be reduced in later years of the award.

The applicant must include funds for the Coordinating Center PD/PI and key personnel (as needed) to attend one in-person 1.5-day meeting of the program steering committee in the first year and one meeting per year for the remaining four years. The meetings will take place in or near Bethesda, Maryland. Other (non-budgeted) steering committee meetings will be held as teleconferences.

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

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

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

Specific Aims:

Outline the general objectives of the proposed Coordinating Center and the overall approach for achieving these goals. Explain how the proposed Coordinating Center will be organized to address the three specific objectives described in Section I.]

Research Strategy: The Research Strategy section must consist of subsections A-B as defined below.

Subsection A: Coordinating Center Overview.

• Provide an overview of the proposed Coordinating Center and its role in the Consortium addressing the primary responsibilities identified in Section I, indicating how the Coordinating Center can facilitate and enhance the work of the Research Centers and the entire Consortium.
• Highlight unique approaches of the proposed Coordinating Center that reflect effective and innovative ways of coordinating multi-institutional trans-disciplinary research
• Describe approaches to Consortium coordination, oversight of a Steering Committee, and any relevant working groups
• Without repeating information in individual biosketches and Facilities and Other Resources, summarize the collective capabilities of the team and previous accomplishments, in areas vital to the role of Coordinating Center, including (but not limited to):
• Coordination/management/organizational support of collaborative research efforts/programs in healthcare delivery research with emphasis on the aspects of focus for this FOA (including symptom management and implementation science);
• Ability to manage multi-site clinical and patient-reported data, including the use of CDEs, standardized procedures for data collection, data quality control/quality assurance, etc.
• Statistical expertise pertinent to health services and outcomes research including statistical analyses and dissemination of study results;

Subsection B. Plans and Approaches to Basic Coordinating Center Functions

Describe plans for the creation and maintenance of the Coordinating Center that addresses all of the aspects, attributes, and functions identified in Section I. 

Consortium Coordination

• Administrative coordination of Consortium activities and providing logistical/operational support,
• Arranging Steering Committee meetings, other Consortium meetings and conference calls,
• Developing and maintaining all formal Consortium documents, including Manual of Operations and other procedure manuals

Ensure standardized, harmonized data collection across the Research Centers

• Designing and ensuring effective procedures that ensure data quality and completeness
• Develop processes that ensure the use of common data elements across the Research Centers (e.g., when Research Centers collect similar outcomes, facilitate use of common instruments, determine uniform data reporting for common elements and scoring as needed)
• Demonstrate technical and intellectual capacity to provide oversight of data sharing within the Consortium, including the development of combined datasets

Establish processes for pooled analyses

• Describe capacity for storing data and data security for pooled Consortium datasets
• Demonstrate capacity and expertise to develop and maintain integrated research databases for combined Consortium data
• Provide plans for the development of analytic approaches for data analysis of combined data from Research Centers
• Demonstrate background and experience with the coordination of analysis of large, combined datasets

Health Disparities. Address how populations with health disparities will be addressed. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. Efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Addressing the Cancer Moonshot Public Access Strategy: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing strategy that requires open access to all research results and underlying data for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative. NCI will give competitive preference and funding priority to applications with a data sharing plan that complies with the strategy described here. The data sharing plan will become a term and condition of award.
• Guiding Principles for Cancer Moonshot Biobanking Activities: The goal in developing these guiding principles is to accelerate research by a) increasing the availability of biospecimens for Cancer Moonshot-related and other biomedical research through facilitation of investigator to investigator sharing of biospecimens, and b) increasing the reproducibility of Cancer Moonshot research through improved biospecimen practices and corresponding annotation. These guiding principles also seek to facilitate, where possible, increased engagement of research participants through researchers communication of aggregate research results and, in some cases, individual genomic findings that may be medically actionable for research participants.  NCI will give competitive preference and funding priority to applications that conform to the "Guiding Principles for Cancer Moonshot Biobanking Activities" (http://biospecimens.cancer.gov/programs/cancermoonshot/principles) and are consistent with the "2016 NCI Best Practices for Biospecimen Resources" (https://biospecimens.cancer.gov/bestpractices/).

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies [e.g. genome-wide association studies (GWAS)]), types of outcomes (e.g., PROs), and patient registries. NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. For NCI-relevant CDEs, please visit  CDE (Common Data Element) Browser.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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).

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.

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

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing implementation research in cancer control? Do the investigators demonstrate significant experience with coordinating collaborative clinical 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 Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience with data harmonization, data security and storage, and statistical knowledge to plan analyses of the combined data from the Research Centers, and experience in facilitating collaborative research with a variety of stakeholders?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects the 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?

Specific to this FOA:

Does the application challenge and seek to shift current research or clinical practice paradigms, national policies and practices, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an ongoing basis?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the projects are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects? Is 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?

Specific to this FOA: 

Will the proposed approach allow for the Coordinating Center to effectively collaborate to share information and best practices across the entire Consortium? Are the plans for administrative support of the Consortium and its Steering Committee sufficient? Does the application contain acceptable plans for addressing the NCI Cancer MoonshotSM Public Access and Data Sharing Policy?

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

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.

For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

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

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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

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).

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

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

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:

• 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.
• Will receive a written critique.

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.

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.

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 grantee’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.

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, Grantees, 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 resides with the awardees for the project as a whole, 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 the overall research objectives;
• Determining approaches, designing protocols, setting project milestones, and overseeing the conduct of the trial;
• Overseeing and coordinating the effort of the multi-disciplinary team and participating institutions and ensuring their optimal integration;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
• Adhering to the NIH policies regarding intellectual property, data release, and other policies that might be established during the course of this activity;
• Submitting updates on human subject and accrual reports;
• Participating as Members of the Steering Committee;
• Implementing guidelines and procedures developed by the Steering Committee;
• Participating in monthly teleconferences with NCI program staff;
• Coordinating and attending annual in-person Steering Committee meetings.
• Awardees will retain custody of and have primary rights to the data, technologies, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.
• Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example The NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research.
• Coordinating with and leveraging, where feasible, the technology of The NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact (cbiit.cancer.gov/cancerdatacommons).
• Meeting annually with other Moonshot U24 coordinating centers to help coordinate the sharing of data, research resources, tools/platforms, and access to newly established biorepositories across the Moonshot initiatives.

Each Consortium awardee and the entire Consortium programmatic initiative will be subject to external evaluation (coordinated by the NIH); Consortium Awardees will be expected to participate in such evaluations.

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.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI Program Directors serving as a Project Scientist(s) will be involved in assisting and coordinating interactions and collaborations among the various investigators.

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. Program Officials may also have substantial programmatic involvement (as Project Scientists).

Specific activities of substantially involved NCI staff members will include:

• Monitoring the operations of Consortium components and activities;
• Reviewing the progress the Consortium;
• Making recommendations to the Steering Committee on strategic directions and improvements to components and activities;
• If appropriate, collaborating scientifically on research projects involving Consortium investigators;
• Advising the awardees on specific scientific issues as well as programmatic priorities;
• Facilitating access to NCI resources and expertise;
• Serving as liaison between the Consortium investigators and NCI staff members;
• Monitoring the scientific progress of the entire Initiative;
• Participating on the Consortium Steering Committee;
• Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.
• Promoting collaborative research efforts that involve interactions with other NCI-sponsored programs, projects, and centers;
• In cooperation with the NCI Center for Bioinformatics, assisting the awardees with relevant aspects of bioinformatics and/or information technology;
• Coordinating external evaluation of the Consortium.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.  In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the Consortium. The Steering Committee will be composed of the following voting members:

• Two representatives from the U24 Coordinating Center award and two each from the UM1 Research Center (the PD(s)/PI(s) or a PD/PI and a designated senior investigator) who will have one vote each; and
• NCI Project Scientist(s) (who will have one vote).

Additional NIH staff members, and at least one cancer survivor (advocate) serving in an advisory capacity, may participate in these meetings as non-voting members. This decision will be made by the existing voting members of the Steering Committee. These members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

The Chair of the Steering Committee will be selected from the representatives of all awardees.

The Steering Committee will meet monthly via phone conference and in person once every year, at locations selected by the Steering Committee in consultation with the NCI. Applicants should budget for in-person meetings to occur in the Washington, D.C., metropolitan area.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientists will serve on such sub-committees, as they deem appropriate.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

• Setting the overall research priorities for the Consortium and identifying emerging research opportunities which can be best explored through a joint collaborative effort via the Consortium;
• Establishing general Consortium policies and procedures;
• Establishing policies and procedures for collaborative projects, protocols, and Consortium-defined projects, including defining how such collaborative activities/ studies (to be supported by the restricted set-aside funds on each award) will be initiated, formulated, and presented to the Steering Committee for recommendation regarding collaborative execution.

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.

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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Ashley Wilder Smith, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6714
Email: smithas@mail.nih.gov

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

Crystal Wolfrey 
National Cancer Institute (NCI)
Telephone: 301-496-8634 
Email: wolfreyc@mail.nih.gov

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

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