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 the Metabolic Dysregulation and Cancer Risk Program: A Transdisciplinary Approach to Obesity-Associated Cancer Research (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • July 07, 2021 - Pre-application Webinar for Metabolic Dysregulation and Cancer Risk Program: a Transdisciplinary Approach to Obesity-Associated Research - RFA-CA-21-021 and RFA-CA-21-022. See Notice NOT-CA-21-094.

Funding Opportunity Announcement (FOA) Number
RFA-CA-21-022
Companion Funding Opportunity
RFA-CA-21-021 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.393
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) will support a Coordinating Center to facilitate coordination across the consortium of multiple individual research project grants for the Metabolic Dysregulation and Cancer Risk Program (U24; RFA-CA-21-022) whose overarching goal is to enhance our knowledge of the dynamics, and underlying mechanisms, that link obesity, metabolic dysregulation, and increased cancer risk.

The Coordinating Center will have several responsibilities, including, but not limited to: provide administrative support to the Metabolic Dysregulation and Cancer Risk Program, facilitate and participate in collaborative research, coordinate the development of standard operating procedures and best practices to identify common measures/targets, collect core common data elements and biological samples (when appropriate), facilitate communication across researchers, provide meeting support, coordinate reviews of cross-consortium pilot project applications and/or activities, create and maintain the website, and facilitate deposition of data to NIH repositories (when appropriate).

Key Dates

Posted Date
July 06, 2021
Open Date (Earliest Submission Date)
September 06, 2021
Letter of Intent Due Date(s)

September 6 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 06, 2021 Not Applicable Not Applicable March 2022 May 2022 July 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.

No late applications will be accepted for this Funding Opportunity Announcement

Expiration Date
October 07, 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 (NCI) solicits applications for a Coordinating Center to facilitate coordination and collaborative research among multiple individual research project grants (see companion RFA-CA-21-021; U01) as part of a Consortium for the Metabolic Dysregulation and Cancer Risk Program.

Overall Goals of the Metabolic Dysregulation and Cancer Risk Program: to identify tangible mechanistic/etiologic pathway(s) that link obesity-related metabolic dysregulation with cancer risk to inform cancer prevention strategies.

Short-term goals of the Program include:

  • Understanding the mechanisms of how obesity-related metabolic dysregulation affects cancer initiation and development;
  • Developing common measures for obesity-related metabolic dysregulation for different cancer types;
  • Characterizing signal cross-talk between key biologic processes (e.g., adipose inflammation, sex-hormones, oxidative stress, and immune function) that impact obesity-associated metabolic dysregulation and cancer risk; and
  • Determining the utility of emerging approaches (e.g., metabolic profile for risk stratification) for the discovery of novel obesity-associated metabolic targets in cancer risk and prevention.

Applicants responding to this Coordinating Center FOA are expected to familiarize themselves with the companion FOA (RFA-CA-21-021; U01) and the features associated with the individual research project grants and the research objectives as well as the related activities and individual and joint responsibilities required for all Awardees of the Metabolic Dysregulation and Cancer Risk Program.

Key Terms and Definitions for this FOA

  • Metabolic Dysregulation: For the purpose of this FOA, metabolic dysregulation is defined as any alteration in glucose utilization and storage, insulin sensitivity, and/or lipid metabolism.
  • Metabolic Dysregulation and Cancer Risk Program: Refers to the NCI coordinated activities, funding and stewardship of research activities related to the metabolic dysregulation and cancer risk initiative. The initiative is a consortium comprised of research teams from individual research grants and Coordinating Center, activities facilitated by the Coordinating Center, and guidance from NCI Program Staff. The term "Consortium" may be used to reference the Metabolic Dysregulation and Cancer Risk Program hereinafter.
  • Steering Committee: The Steering Committee will be comprised of representatives from the funded individual research grants, the Coordinating Center, and designated NCI Program Staff. It will serve as the governance for the Metabolic Dysregulation and Cancer Risk Program through regular meetings, coordinated activities, and communications. The Steering Committee will lead, prioritize and coordinate collaborative scientific activities and efforts to facilitate scientific synergy within the Consortium. Activities may include: i) recommendations for common measurements of exposures and/or endpoints; ii) collection of scientific data; and iii) coordinating efforts across two or more individual research grants (e.g., pilot projects linking unique resources).
  • Individual Research Project Grant: a research grant funded through the companion RFA-CA-21-021 to investigate the link between metabolic dysregulation and cancer risk.

Background

The obesity-cancer link is a pressing concern due to the escalating prevalence of obesity. Obesity can be conceptually viewed as a “disease-susceptible state” and, of relevance, a “metabolically dysregulated state.” This state of disease predisposition has the potential to progress to cancer and other chronic pathologies. The Metabolic Dysregulation and Cancer Risk Program initiative seeks to support research projects to identify critical mechanistic/etiologic pathway(s) that link obesity-related metabolic dysregulation with cancer risk to inform cancer prevention strategies. The initiative intends to foster transdisciplinary research that cuts across different scientific domains to allow investigators from multiple disciplines to come together to advance discovery, translation of current knowledge or emerging findings, and ultimately extend our understanding on the mechanisms linking metabolic dysregulation and obesity-associated cancer risk. A Consortium (comprised of funded investigators for the individual research grants, the Coordinating Center, and NCI Program Staff) will be established and governed by a Steering Committee. Awardees of funded research project grants and the Coordinating Center will be expected to participate in this Consortium, engage in efforts to optimize synergy across projects, and to collaborate in pilot projects that may emerge within the Consortium.

This FOA seeks to support a Coordinating Center to facilitate communication, synergy, and integrate efforts across the individual research projects to facilitate cross-fertilization and transdisciplinary research. The Coordinating Center provides administrative, meeting, and scientific support to achieve the goals of the Metabolic Dysregulation and Cancer Risk Program as described below.

Specific Research Objectives and Requirements

General Requirements for the Coordinating Center

The Coordinating Center will have a central role in integrating the efforts of individual research project grants to be funded under its companion FOA (RFA-CA-21-021; U01).To fulfill this role, the Coordinating Center applicant team must demonstrate substantial experience in: (1) coordinating large multi-site programs, (ii) providing logistical infrastructure for such programs, and (iii) coordinating collaborative research that emerges from cross-fertilization of scientists across multiple disciplines.

The Coordinating Center will be expected to handle the operation logistics, contribute scientific inputs as participating member of the Consortium, and provide administrative and analytical support for individual research project grants. The Coordinating Center will work with Awardees of the individual research project grants and NCI Program Staff to bring together expertise and data relevant to the funded research and to meet the Consortium’s goals outlined above. The Coordinating Center should be able to connect available resources and serve as a research data management center.

The Coordinating Center will be expected to identify and support the integration of activities of the awarded individual research project grants to minimize resources/effort duplication and utilize existing resources available. The Coordinating Center will have substantial responsibility for the continued self-evaluation of research awardees and the evaluation of the entire Metabolic Dysregulation and Cancer Risk Program.

Applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the special requirements mentioned in the FOA. The same institution may submit applications to this U24_RFA and its companion U01,RFA-CA-22-021, so long as there is no overlap regarding investigators and direct cost funding.

Strategic Goals for the Coordinating Center

The Coordinating Center applicant team should be cross-disciplinary with expertise aligning with the topic areas of the Metabolic Dysregulation and Cancer Risk Program. The Coordinating Center must address the following strategic objectives:

  • Identify scientific problems that could be jointly explored by members of the Consortium and coordinate development of collaborative projects as recommended by the Steering Committee.
  • Identify commonalities in measures and targets that could be incorporated across multiple research project grants.
  • Facilitate transdisciplinary research through scientific leadership and organizational support with emphasis on efficient communication, coordination of efforts, and scientific collaboration across multiple research institutions.
  • Identify and facilitate scientific synergy across the Consortium involving at least two research awardees (see Collaboration Core for details) and coordinate the utilization of the pool Collaborative Funds.
  • Provide logistical support for Consortium activities by providing state of the art cross-project communication approaches (i.e. listservs) and a project web site and working with NCI program staff and Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the individual research projects to organize the biannual meetings.
  • Coordinate announcement of funding opportunities for cross-consortium collaborative research (see Collaboration Core), review of applications, and funding of successful applications.
  • Foster and create opportunities for training of early-stage scientists interested in the area of metabolic dysregulation, obesity, and cancer risk.
  • Create and manage relevant logistic and analytical infrastructure (including research data management and bioinformatics) to support the Metabolic Dysregulation and Cancer Risk Program.
  • Create opportunities and assist in coordination of meetings to disseminate results across multiple venues.
  • Organize annual meetings and regular conference calls for the Steering Committee and Work Groups, awardees and collaborators, and the public (if applicable).

Required Structure and Main Components of the Coordinating Center

All applicants must address the following main features:

1a. Leadership and Administration. The Coordinating Center must be able to provide close coordination of transdisciplinary research efforts of the Metabolic Dysregulation and Cancer Risk Program. This role will require strong leadership, scientific insight, and capacity to bring diverse teams together.

Because of the central requirement for interactions across the Metabolic Dysregulation and Cancer Risk Program, the Coordination Center will be responsible for the following activities:

  • Provide scientific leadership and serve as an intellectual/scientific hub for members of the consortium;
  • Facilitate synergy and collaborations across a diverse group of researchers;
  • Provide assistance to the Steering Committee's overall management and bringing together appropriate experts to advise Steering Committee;
  • Compile state-of-the-art instruments for multiple methodologies, biomarkers, and other relevant measures in use across the consortium, and leveraging their use;
  • Provide logistic and administrative support for all the activities of the Steering Committee and its subcommittees, including the External Advisory Board (if established)
  • Coordinate self-evaluation and integration (see more detail below under Integration and Self-Evaluation Core).

1b. Logistic and Administrative Responsibilities. In addition to scientific and leadership support of the Metabolic Dysregulation and Cancer Risk Program, the Coordinating Center must be able to provide logistic and administrative support to each research project grant funded under the companion RFA-CA-21-021, and other activities, including but not limited to:

  • Help establish topical “Work Groups”, as recommended by the Steering Committee, which are relevant to the funded research and scientific needs across the Consortium;
  • Provide logistical infrastructure serving the research awardees and facilitating Consortium-related functions and activities;
  • Provide provision of a public website for communication and sharing of activities, events, and resources of the Consortium;
  • Provide organizational and logistical support for facilitating the activities of the Steering Committee and Work Groups;
  • Support standards and mechanisms for publicly sharing data, resources, and codes developed and utilized in the Consortium, including by the Coordinating Center;
  • Organize and support the logistics of semi-annual or annual investigators meetings (with cooperation and approval from NCI designated program staff) and meetings of topical Work Groups (either virtually or in-person at a designated geographic location). In addition to the annual investigator meeting, upon successful funding, the Coordinating Center must be able to convene a kick-off meeting within the first 30 days of the release of the Notice of Grant Award.

2. Data and Bioinformatics. The Coordinating Center will be responsible to develop a Central Data Hub (Bioinformatics Core) and provide bioinformatic support as needed and in collaboration with research awardees. The main goal of this component is to facilitate data sharing and results dissemination across awardees and between awardees and NCI.

The Bioinformatics Core support must provide infrastructure for data collection and archiving to meet standards for common data systems and future data repositories. Specifically, informatics and data sharing approaches proposed for the Coordinating Center must be compliant to all NIH data sharing policies.

It is expected that this Core will strongly involve resources and personnel that will interact with the funded individual research project grants.The data management functions of the Coordinating Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site.

3. Outreach. The Coordinating Center must include an outreach program that is integrated across all individual research project grants. Plans for this component must include the following elements:

  • Facilitate integration and promote research. The outreach efforts of the Coordinating Center must include the setup and maintenance of a website for investigators as well as a public, generally accessible website for the Metabolic Dysregulation and Cancer Risk Program;
  • Organize sessions to present the research findings/outcomes at relevant national meetings.

4. Collaboration Core. Awardees of the Metabolic Dysregulation and Cancer Risk Program are required to participate in cross-Consortium activities (see Section VI.2, Cooperative Agreement Terms, and Conditions of Award for further details). The Coordinating Center will be responsible for coordinating cross-Consortium activities (i.e. collaborative research to be developed and conducted by awardees post-award). Funding for cross-Consortium activities, including pilot projects, will be supported in part by restricted Collaborative Funds (See below and Section II.R&R and Modular Budget for further details). Specifically, plans for this Collaboration Core include the following, but are not limited to:

  • Identify common measures/targets that can be incorporated between at least two research project grants to facilitate downstream pool analysis and investigations within the Consortium;
  • Identify commonalities in research directions and specific questions being explored across the Consortium to promote cross-initiative collaborative efforts;
  • Identify a scientific problem (i.e. cross-consortium pilot project) that could be jointly explored across research project grants during the lifespan of the Consortium.

Collaborative Funds for Developmental/Pilot Projects

Collaborative Funds (see Section IV.2. R&R and Budget for further details) can be used to support the expansion or inclusion of an exploratory aim to incorporate identified common measures or targets, develop new methodologies that can be validated via multiple grants, or facilitating diverse study population. This restricted fund may be combined with other award recipients' Collaborative Fund. Collaborative Funds may also be used to fund cross-Consortium pilot projects or developmental ideas with one or more award recipients within the Consortium and may involve outside investigator(s) (not recipient within the Consortium). The outside investigator(s) must bring a desirable expertise that is not already part of the Consortium and must meet the purpose of the Metabolic Dysregulation and Cancer Risk Program. The inclusion of outside investigators will require appropriate justification and approval from the Steering Committee. Proposed pilot projects without the inclusion of other award recipients are considered ineligible for the use of Collaborative Funds. Collaborative Funds should not be used for activities that have been supported under the awards for individual research project grants and outside the scope of the outlined goals of the initiative. Usage of Collaborative Funds to enable conduct of multi-year cross-consortium pilot project or activities are allowable. The Coordinating Center may choose to use its Collaborative Fund to provide educational opportunities (e.g. travel awards) for early-stage investigators or students to the Consortium's meetings.

5. Integration and Self Evaluation Core. The Coordinating Center must have the capacity to enable timely self-evaluation mechanisms promoting effective self-correcting actions. In this area, the Coordinating Center will have to closely collaborate with the Steering Committee (see below) and possibly other members of the funded research project grants, and NCI program staff. An appropriate evaluation system is expected to be integrated into the Coordination Center’s design and operations.

This self-evaluation system should track the relevant performance benchmarks of the consortium, taking into consideration the individual accomplishment of each research project grant and any collaborative endeavors. The outcomes will help Steering Committee and individual awardees to take corrective steps and optimize their performance.

The self-evaluation of the Awardee (and the activities of this component) will be essential to facilitate and enhance the overall evaluation of the Consortium, to be determined by NCI. The Coordinating Center (and specifically this Integration and Self-Evaluation Core) will be expected to cooperate with NCI in the evaluation process. For example, this component includes evaluating the quality and innovativeness of the science conducted by the individual research project grant as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building, cross-fertilization, linkages and resource sharing arrangements within and among the consortium, and the interdisciplinary and multilevel nature of the research. Evaluation variables may include items such as peer-reviewed publications, developed web sites, joint collaborative grants submitted for funding outside of the Consortium, or other new collaborations and partnerships.

Areas for the self-evaluation and desirable outcomes will include such aspects as:

  • The overall capacity to study the mechanisms underlying the association between metabolic dysregulation, obesity and cancer risk;
  • The capacity to study the relationship between markers of metabolic dysregulation and cancer risk, modifiable factors such as the microbiome or sleep as they relate to the goal of reducing cancer incidence and lessening a high-risk metabolic abnormal profile;
  • The contribution to these capacities of resource sharing and collaboration within and among Awardees;
  • The effectiveness of collaborative relationships within and among Awardees;
  • A “transdisciplinary research culture” engendered which takes into account the perspectives of multiple disciplines and multiple levels of analysis; and
  • Awarded investigators’ abilities to compete for future R01 grants and participate in other research mechanisms have been enhanced.

Overall Structure of the Metabolic Dysregulation and Cancer Risk Program

The Metabolic Dysregulation and Cancer Risk Program will include Awardees of the individual research project grants (RFA-CA-21-021) with scientific expertise that cuts across basic science, metabolism, oncology, epidemiology, and intervention/prevention research and the Awardee of the Coordinating Center. Awardees should identify shared resources that can support needs across the Consortium and optimize synergy and facilitate the collaborative nature and impact.

Upon successful funding, members of the Consortium will be required to participate in a virtual kick-off meeting which will take place within 30 days of the release of the Notice of Award (NOA). Awardees will be required to attend a yearly face-to-face annual meeting and other topic-specific smaller meetings (as appropriate) for the exchange of scientific information across the Consortium. The Coordinating Center, in conjunction with NCI staff, will facilitate cross-Consortium collaborative activities among the individual research project grants and identified partners. The Metabolic Dysregulation and Cancer Risk Program will be governed by a Steering Committee comprised of representatives from the funded individual research grants, the Coordinating Center, and NCI Program Staff.

Governance

The Steering Committee will be comprised of the PI of each individual research grant, the PI of the Coordinating Center, and NCI Program Staff. Though the Steering Committee will make recommendations, NCI Program Staff will have final authority to approve or reject any proposed recommendations. All consortium-related activities must comply with NIH, DHHS, and Federal Guidelines.

Additional details on the composition and functions of Steering Committee are provided in Section VI.2, Cooperative Agreement Terms, and Conditions of Award.

Non-Responsive Applications

The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewe

  • Applicants that do not provide explicit adherence into data/resource sharing plans and not following FAIR principles (see https://www.go-fair.org/fair-principles/) for Resource Sharing Plans as provided in SF 424 Application Guide).

NOTE: Applicants to this FOA or the companion RFA-CA-21-021 are strongly encouraged to attend at least one of two planned pre-application webinars sponsored by the NCI and contact the designated NCI Program staff as soon as possible in the development of the application (preferably no later than 12 weeks prior to the application due date) to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this FOA.

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

NIH intends to fund one award, corresponding to a total of $800K, for fiscal year 2022.

Award Budget

Application budget may not exceed $550,000 in Direct Costs per year and must reflect the actual needs of the proposed project .

Award Project Period

The total project period may not exceed 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 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).

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 NCI Staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Tram Kim Lam, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6967
Email: lamt@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.

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.

Restricted Collaborative Fund for cross-Consortium activities: To facilitate synergy within the Consortium and to achieve unmet scientific priorities of the Metabolic Dysregulation and Cancer Risk Program, Awardees of the Metabolic Dysregulation and Cancer Risk Program must budget appropriate funds designated as "Collaborative Fund” to facilitate cross-Consortium activities (see Section I.Collaboration Core and Section VI.2, Cooperative Agreement Terms and Conditions of Award). Specifically for the Coordinating Center, $25,000 in direct cost per year must be allocated as Collaborative Fund (and should be presented in the Other Expenses category under the heading "Collaborative Fund"). During Year 1 of the award, flexibility is allowable for modification of Specific Aims and associated milestones. Carryover of Year 1 Collaborative Fund is permitted with approval from NCI Program Staff. Collaborative Fund cannot be rebudget and unobligated fund, in any year, may be offset as per the recommendation from NCI Program Staff.

Travel Funds: The budget should include funds to support travel for Consortium-related activities, including but not limited to supporting the participation of PD(s)/PI(s) and other team members in annual meetings and/or ad hoc meetings related to the Consortium. Specifically, applicants will be required to budget for a key personnel and team members/ collaborators (in aggregate, up to three members) to attend one annual face-to-face investigator meeting.

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 of the Coordinating Center to meet the needs of the Consortium and to advance the goals and objectives of the Metabolic Dysregulation and Cancer Risk Program. Specific aims should address the required structure and main components as described in Section I.2.

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

Sub-section A: Background and Significance

The applicant should describe:

  • Overview of how the proposed research coordination approach will advance the goals of the Metabolic Dysregulation and Cancer Risk Program;
  • Without duplicating information in the biosketches:
    • Overview of leadership, cross-disciplinary team, and organizational structure to advance the goals of the Consortium;
    • Prior experience in bringing together a diverse group of scientists;
    • Leadership in identifying synergy and collaborative opportunities within a Consortium.

Sub-section B: Innovation

Critical to the success of the Consortium is optimizing synergy across members and to identify cross-Consortium activities, including pilot/developmental project(s) and/or integration of common measures/targets, which could not be pursued by individual U01 research sites. Describe how the proposed application works to facilitate and optimize this opportunity.

Sub-section C: Approach

Provide a detailed overview of the proposed Coordinating Center. Description of the administrative and scientific responsibilities should include, but not be limited to, the following features:

  • Bring together expertise from across the Consortium to synergize scientific engagement and establish topical “Work Groups” (such as groups focused on markers of metabolic dysregulation and measurement, obesity-metabolism-cancer link, or translation) relevant to the funded research and scientific needs across the initiative;
  • Provide logistical support for all the activities of the Steering Committee and its subcommittees;
  • Enable state-of-the-art cross-site communication for Awardees;
  • Organize annual/scientific meetings and regular conference calls for the Steering Committee and its subcommittees, Consortium-supported investigators, and the public/scientific community.

Inclusion of the following components is recommended.

Developmental Cross-Consortium Coordination

The applicant should describe, though not be limited to:

  • Capability to promote, synergize and facilitate collaboration across multi-site studies within the Consortium and among investigators to identify common measures or constructs and standardize procedures for data collection and analysis;
  • Proposed approach to identify commonalities in research directions and specific questions being explored across individual research projects;
  • Capability to identify, collect, facilitate assessment and measurement, share, and/or harmonize common measures/targets for usage by members of the Consortium;
  • Methods to facilitate, document, and promote standardization of research approaches and sharing of resources across the Consortium working on common issues;
  • Plans for coordinating and facitiating management of the “Collaborative Funds”, including soliciting the assay of common measures/targets (e.g., insulin resistance) or pilot project proposals and how potential cross-Consortium projects will be identified, selected, and managed;
  • Innovative value and potential of the proposed Coordinating Center functioning for facilitating transdisciplinary research in metabolism, obesity, and cancer risk; and
  • Compile state-of-the-art methods for data collection, novel biomarkers, laboratory procedures and models in use across the Consortium, and leverage their use.

Resource and Data Sharing and Bioinformatics

The applicant should describe, though be not limited to:

  • Capabilities to support proposed trans-Consortium projects and data sharing among the Consortium members, for example, through the establishment and maintenance of a secure internal Consortium web portal, access to existing data storage and management infrastructure, etc.;
  • Access to specialized expertise in biostatistics, bioinformatics and/or software development, as needed;
  • Capabilities to facilitate the development of publication, biospecimen, and data use policies. Note that the data management functions of the Coordinating Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site. However, the Coordinating Center may also serve as a clearing house for data storage and management to the extent that common data elements will be collected across multiple research projects and it is determined that centralization of such data would be beneficial to the Consortium by the Steering Committee; and
  • Other innovative methods by which the Coordinating Center will stimulate communication and resource and information sharing across the Consortium members.

Education and Outreach

The applicant should describe, though not be limited to,:

  • Capabilities to support the establishment and maintenance of an external Consortium website;
  • Capabilities to provide and foster education for junior investigators and students;
  • Proposed methods to facilitate communication between the Coordinating Center and investigators/community partners in the overall Program as well as investigators involved in complementary research outside of the Program;
  • Outreach activities and relevant methods to disseminate information about the Program and its results to breast cancer and environment research and advocacy communities, including workshops, external seminar series, sessions at scientific meetings, etc.

Internal Evaluation

The applicant should describe:

  • Capability to design an internal evaluation framework for the Consortium, track relevant metrics, and disseminate results;
  • Methods for evaluating the overall performance and implementing corrective actions if required.

Letters of Support: Applicants must include letters of support from collaborating entities that are essential to the mission of the work proposed.

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, must address a Data Sharing Plan.
  • Applicants must propose a data sharing plan that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable).
  • Data Sharing Plan must be consistent with accomplishing the goal and objective of the initiative and optimizing access to data, resources, and products generated from Consortium-related activities.

Note: NCI Program Staff may negotiate modifications to these plans prior to funding or post-award.

Intellectual Property Policy: Consistent with achieving the goals of this program and maximizing the benefit of all research funded as part of the Consortium for the improvement of public health through discoveries of the scientific community, the Data Sharing and Data Release policies expect a broad freedom-to-operate for all users of data generated by members and/or collaborators of the Consortium (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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. 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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: How well does the proposed application address the needs of the Consortium that it will coordinate? How well does the scope of the application's proposed approaches meet those needs? Do the proposed aims sufficiently advance the operations of the Consortium to meet the goals and objectives of the Metabolic Dysregulation and Cancer Risk Program?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Are the Coordinating Center investigators and key personnel well-qualified for participating and managing multi-site collaborations and facilitatingg interactions and communication among investigators and staff from multiple institutions to optimize synergy? Are the backgrounds, diverse expertise, and commitments of the PDs/PIs and other key personnel sufficient for the proposed scope of activities and in line with the goals and objectives for the Coordinating Center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: How innovative are the proposed approaches and scope of activities to optimize communication and synergy within the Consortium? Are the proposed approaches innovative to facilitate cross-Consortium activities, including identifying common measures/targets between the diverse research projects or pilot projects, and advance the goals and objectives of the initiative?

Approach

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

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

Specific to this FOA:

  • How well does the application describe the approaches that would streamline research processes, improve communication, encourage collaboration, and increase creativity and performance within the Consortium to meet the objectives of the Metabolic Dysregulation and Cancer Risk Program?
  • Does the proposed approach address critical challenges and proposed strategies to optimize synergy between a diverse group of researchers?
  • How well described is the applicant's plan for the identification, collection, standardization, and harmonization of measures and/or endpoints?
  • Does the plan for resource and data sharing and bioinformatics describe a Coordinating Center that will efficiently support the sharing of data and information resources across the Consortium?
  • Are the proposed outreach and education activities (if applicable) appropriate and adequate to support the goals of the Consortium?
  • Is the proposed plan to synthesize and disseminate research results adequate to provide meaningful information to both researchers and community stakeholders?
  • Does the evaluation plan demonstrate a capacity for the Coordinating Center to collaborate within the Consortium and NCI program staff on critical evaluation of the transdisciplinary nature of the program and dissemination of research findings?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 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.

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 NCI. 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) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the proposed research in accordance with terms and conditions of the award.

All PD(s)/PI(s) of the Metabolic Dysregulation and Cancer Risk Program (Coordinating Center and individual research projects) will have primary responsibility for:

  • Overseeing the budget and activities of the award, as detailed above;
  • Cooperating with other Consortium investigators and partners and NCI Staff, as appropriate, in the design and conduct of protocols, analysis of data, and reporting of results of research undertaken by the Consortium;
  • Providing goals and estimated costs for procedures and protocols;
  • Sharing data, protocols and other research resources generated through the award;
  • Promoting and coordinating cross-Consortium scientific collaboration;
  • Ensuring training of study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry;
  • Facilitating the formation of and participating in appropriate Work Groups to promote the exchange of preliminary findings, experiences, protocols, and ideas across the Consortium;
  • Interacting and complying with requests for information from the Steering Committee and other sub-committees as appropriate;
  • Participating in the required annual PD/PI scientific/business meetings, and monthly committee calls organized by the Coordinating Center, as relevant;
  • Contributing to the planning and agenda of annual scientific meeting;
  • Cooperating in the program evaluation activities, as needed;
  • Accepting and implementing all scientific, practical, and policy decisions approved by the Steering Committee to the extent consistent with applicable grant regulations;
  • Serving on the Steering Committee (for details, see "Areas of Joint Responsibility" below);
  • Providing information and materials to the NCI Program Staff, as requested, to facilitate the evaluation of progress and performance, including submitting annual progress reports in a standard format;
  • Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

The PD/PI responsible for the Coordinating Center will have the following additional responsibilities:

  • Organizing the development of Steering Committee and other sub-committees as appropriate
  • Organizing and providing logistical support for Steering Committee, Work Groups and other sub-committees.
  • Budgeting for, organizing, and providing logistical support for the annual Scientific Meeting.
  • Identifying, collecting and managing relevant protocols, data and other resources used by the Consortium members.
  • Coordinating and managing an “Collaborative Funds” for cross-Consortium activities or pilot project program, with significant input from NCI Program Staff and the Steering Committee, to support new transdisciplinary research endeavors questions that emerge from the Consortium.
  • Serving as the executive secretary for the Steering Committee, which at a minimum includes compiling monthly minutes and quarterly summaries of consortium-wide activities.
  • Coordinating cross-Consortium training for individual research projects' personnel as needed for standardization of collaborative protocols across sites, etc.
  • Expanding and promoting the Consortium by actively synthesizing and disseminating relevant results.

The Consortium will be subject to periodic internal evaluation (coordinated by the Coordinating Center and NCI Program staff). Awardees will be expected to participate in such evaluations.

All Consortium awardee institutions/organizations will be expected to share with other awardees knowledge, data, research materials, and any other resources necessary and relevant to the Consortium.

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

One or more NCI Program Directors will be substantially involved in the Consortium as NCI Project Scientists/Collaborators. NIH Project Scientists/Collaborators will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.

NCI Project Scientist/Collaborator(s) will have the following, though not limited to, responsibilities to all Consortium recipients:

  • Have substantial involvement to guide, coordinate, and participate in the conduct of the Consortium activities;
  • Attend and participate in all Steering Committee and subcommittee meetings of the Consortium;
  • Coordinate and facilitate the interactions among the recipients under the cooperative agreements;
  • Serve as a liaison between the Steering Committee, the Consortium, the NIH/NCI and other federal agencies as needed;
  • Monitor the operations of the Coordinating Center and individual research projects, review their progress and compliance with the operating policies of the Steering Committee, and make recommendations on overall project directions and allocations of project funds;
  • Facilitate and coordinate the exchange of information and interactions between Consortium awardees to support collaborative efforts;
  • Participate in organizing and coordinating annual scientific/business investigator meeting and/or other meetings identified at post-award as coordinated by the Coordinating Center;
  • Advise on the design of research activities, availability of resources, and/or management and technical performance of projects, as appropriate;
  • Participate as collaborators to the investigators in some shared activities, if appropriate;
  • Assist in avoiding unwarranted duplications of effort across the Consortium;
  • Provide oversight in the evaluation of the Consortium as coordinated by the Coordinating Center;
  • Monitor progress of the projects towards meeting milestones and adherence to the strategic goals of the program;
  • Facilitate collaborative research efforts and related activities that can involve recipients as well as investigators from other NCI-related initiatives;
  • Evaluate the adherence of recipients to any approved data sharing plans or intellectual property plans.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those recipients' institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

Areas of Joint Responsibility include

A Steering Committee will serve as the governing board for the Consortium. The Steering Committee will have primary responsibility for:

  • Overseeing the overall organization of the Consortium initiative and for reviewing its research goals;
  • Monitoring transdisciplinary progress of the Consortium;
  • Establishing advisory committees and subcommittees, as necessary, to serve the Steering Committee and the recipients;
  • Establishing topical Work Groups for specific purposes, as needed, and developing the appropriate structure to promote the exchange of experiences, protocols, novel research findings, etc. across the Consortium. The NCI Program Staff will serve on such sub-committees, as they deem appropriate and/or designate an NCI representative;
  • Reviewing the potential for sharing resources located at individual research project sites to serve the needs of other projects or the entire initiative;
  • Making recommendations for re-directing the Consortium's focus in order to accommodate new scientific opportunities and directions and maximize the transdisciplinary nature of the Consortium;
  • Sharing and reviewing annual progress among the projects of the Program;

The Steering Committee will be comprised of the following voting and non-voting members:

  • The PD(s)/PI(s) of the Coordinating Center (RFA-CA-21-022), who will have one vote.
  • A research investigator of each individual research projects (RFA-CA-21-021), who will have one vote. Recipients with MPIs must designate a PI as the representing voting member. The non-voting PI of the MPI award may participate in all Steering Committee meetings. The MPIs may alternate role as voting member of the Steering Committee during the lifecycle of the Award.
  • Designated NCI Project scientist/collaborator(s) representing the NCI management group, who will have up to two votes.
  • Other NCI Program Staff members as part of the NCI management group may participate in Steering Committee meetings as non-voting members.
  • Approved ad-hoc members may participate in Steering Committee meetings as non-voting members.
  • Each entity must also designate a stand-by should the voting member is absent or unable to serve.

Other relevant details, including:

  • The PD(s)/PI(s) for each research project grant award and the Coordinating Center will agree to serve at least one 2-year term within the project period.
  • Steering Committee representatives from each project will be elected at the initial kick-off Consortium meeting and should reflect a balance between research investigators and disciplines.
  • The Steering Committee will meet virtually or in person once every year, at a geographical location recommended by the Steering Committee in consultation with the NCI. Recipients are encouraged to host at least one annual meeting.
  • A Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NCI staff cannot serve as Steering Committee Chair.
  • In the event that PD(s)/PI(s) cannot agree on critical aspects of the Consortium, such as common protocols, then the Steering Committee, in consultation with NCI Program Staff, will vote on a recommendation for how to proceed. NCI Program Staff will have final authority to implement proposed recommendations. All activities must comply with NIH, DHHS, and Federal Guidelines.
  • Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.
  • The Steering Committee may establish an External Advisory Board, comprised of scientific experts from outside the Metabolic Dysregulation and Cancer Program, to advise the Consortium.

Cross-consortium Activities:To facilitate synergy within the Consortium to achieve unmet scientific priorities of the Metabolic Dysregulation and Cancer Risk Program, recipients are required to participate in cross-Consortium activities and identified pilot projects as recommended by the Steering Committee. The cross-Consortium activities (see Section 1. Collaborative Funds for Developmental/Pilot Projects for further details) will be developed and conducted by recipients at post-award as part of the Collaboration Core coordinated by the Coordinating Center. Funding for the cross-Consortium activities will be supported in part by set-aside Collaborative Funds.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to Dispute Resolution. The Dispute Resolution Panel will have three members: one NCI designee and two designees with expertise in the relevant area, chosen by the Steering Committee. 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)

Tram Kim Lam, PhD, MPH
Division of Cancer Control and Population Sciences, NCI
Telephone: 240-276-6967
Email: lamt@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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