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

Immuno-Oncology Translation Network (IOTN): Data Management and Resource-Sharing Center (DMRC) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-047

Companion Funding Opportunity

RFA-CA-17-045, U01 Research Project – Cooperative Agreements
RFA-CA-17-046, U01 Research Project – Cooperative Agreements
RFA-CA-17-048, U24 Resource-Related Research Projects – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.353  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. Specifically, this FOA targets the following area designated as scientific priority by the Blue Ribbon Panel (BRP): Recommendation B. Create a translational science network devoted exclusively to immunotherapy approaches to treat and prevent adult cancers. The goal of the network is to foster collaborative team science approaches to accelerate the discover of new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.

The purpose of this FOA is to establish a Data Management and Resource-sharing Center to provide overall support for the Immuno-Oncology Translational Network (IOTN) and to integrate the research activities of the IOTN with other Cancer Moonshot Initiative programs.

Key Dates

 

Posted Date

October 9, 2017

Open Date (Earliest Submission Date)

December 16, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date.

Application Due Date(s)

January 16, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

April/May 2018

Advisory Council Review

August 2018

Earliest Start Date

September 2018

Expiration Date

January 17, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

This funding opportunity announcement (FOA) will establish an Immuno-Oncology Translational Network (IOTN) with the overall goal of accelerating research advances through collaborative team science approaches to improve immunotherapy outcomes for diverse cancers that are either resistant or develop resistance to current immunotherapies. Specifically, this strategy is expected to discover new immune targets and evaluate novel immune-based therapies and combination approaches that eliminate established cancers in adults or to prevent cancers before they occur.

Organization of the Immuno-Oncology Translation Network

Four companion FOAs will support the establishment of the IOTN with the following components:

  • Cancer Immunotherapy Consortium (CIC): The CIC will be composed of organ site-specific Cancer Immunotherapy Research Projects (to be supported by RFA-CA-17-045) and Cancer Immunoprevention Research Projects (to be supported by RFA-CA-17-046). The CIC will form an integrated network of multi-disciplinary, collaborative teams with the overarching goals of accelerating the development of improved immunotherapeutic strategies capable of eliminating established cancers or preventing cancers before they occur. Approximately 10-12 U01s are expected to be awarded in FY18.
  • Data Management and Resource-Sharing Center (DMRC): The DMRC (supported by this FOA, RFA-CA-17-047) will provide overall support, and facilitate collaboration among the adult IOTN-funded components. The DMRC will also promote scientific outreach with other Cancer Moonshot initiatives and the larger scientific community.
  • Cellular Immunotherapy Data Resource (CIDR): The CIDR (one U24 to be supported under RFA-CA-17-048) will support a data registry for collecting outcomes of patients receiving cellular immunotherapies, that could be utilized for observational studies or inform subsequent pre-clinical studies and clinical trials.

Governance of the IOTN: The IOTN, including DMRC, CIDR, and the Cancer Immunotherapy and Immunoprevention Research Project components will be governed by the IOTN Steering Committee. (see Section VI: Terms and Conditions of Cooperative Agreement.)

Evaluation of the Program: IOTN awardees will be required to participate in an external evaluation process of the IOTN program coordinated by NCI Program Staff (see Section VI: Terms and Conditions of Cooperative Agreement.)

The purpose of this specific FOA is to establish a Data Management and Resource-sharing Center (DMRC).

Background

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 establishing a translational science network devoted exclusively to discovering and evaluating novel immune-based approaches to treat and prevent adult cancers. Implementation of the IOTN will address this BRP scientific priority.  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.

Scientific Scope of the Data Management and Resource-sharing Center (DMRC)

The anticipated functions of the DMRC will require three distinct activities or functional modules that include:

1) Network Administration and Coordination (NAC);

2) Resource-sharing and Scientific Outreach (RSO); and

3) Data Integration and Sharing (DIS).

Detailed descriptions of the DMRC functional modules are as follows:

1. NAC: The NAC will serve as the administrative and organizational hub and will work closely with IOTN Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to facilitate collaboration among all IOTN-funded components and coordination between the IOTN and other National Cancer Institute (NCI) supported initiatives or networks.

The NAC will coordinate all IOTN governing and advisory bodies including the Steering Committee, subcommittees and working groups, and external scientific panels and organize an annual IOTN consortium-wide grantees meeting.

In addition, the NAC will facilitate interactions between the IOTN and other NCI and NIH supported consortia, bio-repositories, databases, or non-profit organizations involved in activities relevant to the mission of the IOTN.

2. RSO: The RSO will support sharing and distribution of IOTN-generated resources among IOTN PD(s)/PI(s) and between the IOTN and the scientific community.

The RSO will develop a central IOTN website that will constitute the main entry point for the sharing of resources and information related to IOTN activities and a Virtual Biorepository to oversee tracking and distribution of organ site-specific biospecimens, models, tools and technologies, and other resources.

In addition, the RSO is required to work closely with IOTN PD(s)/PI(s) to obtain data, protocols, tools and technologies, and information on biospecimens and other resources and make the scientific community aware that this information is publicly accessible.

3. DIS: The DIS will provide essential bioinformatics and computational support for the design, collection, management, and analysis of data (including genomic data, tumor targets, cellular analyses, and others) for all IOTN-funded components.

The IOTN is expected to generate varied and complex data including circulating and tumor-infiltrating immune cell parameters; cell subset analyses; immunohistochemistry; and various types of genomic, epigenomic, transcriptomic, and proteomic datasets.

The DIS is expected to work closely with IOTN PD(s)/PI(s) to obtain datasets and necessary metadata, perform initial quality control, and ensure data are deposited in the appropriate databases.

Other DMRC Application Considerations

As the data generation, storage, analysis, and dissemination needs of the IOTN evolve over time, the DMRC may be asked to implement modifications to its workflows as agreed upon by the IOTN investigators and NCI staff. In addition, increasing efficiencies in generating data along with potential changes in technology platforms may dramatically alter the types and volume of data to be deposited, curated, and analyzed by the DMRC. Further, the data will likely be generated across many organ sites and cancer-relevant transitions, adding another layer of complexity to the curation and mining of the data. The DMRC should be flexible in their implementation of data coordination, analysis, and outreach workflows.

Non-responsive Studies

Applications which do not include a description of all three DMRC modules (NAC, RSO, and DIS) will be viewed as non-responsive and will not be reviewed.

Applicants are encouraged to reach out to the Scientific/Research Contact listed in Section VII below to ensure appropriate alignment of projects with available funding opportunities.  

Pre-Application Teleconference

A technical assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this FOA. Time, date, and dial-in information for the call will be announced in an NIH Guide Notice.

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.

Funds Available and Anticipated Number of Awards

NCI intends to fund one award corresponding to a total of $1,275,000, for FY 2018.

Award Budget

The applicant may request a budget of up to $750,000 in direct costs in FY 2018.

Award Project Period

 A project period of 5 years must be requested.  

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.

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • 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) (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.
  • o   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.

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

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Kevin Howcroft, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6229
Email: Howcrofk@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.

Applicants must budget for travel and per diem expenses for Steering Committee meetings. In the first year, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PD(s)/PI(s) option is not used), to attend a Planning Meeting and one Steering Committee Meeting. In the second and subsequent years, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PD(s)/PI(s) option is not used) to attend one Steering Committee meeting per year.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The applicant is to provide the overall objective for the DMRC and the plans to achieve these goals listed in well-defined specific aims.

Research Strategy: Organize the Research Strategy to include an Overview of the overall project and address in Sub-sections A – D identified below.

Sub-section A. DMRC - Network Administration and Coordination (NAC)

Address the anticipated activities of the NAC that include (but are not limited to):

  • Provision of the administrative infrastructure necessary to facilitate and coordinate all common activities of the IOTN;
  • Organization and coordination of all IOTN governing and advisory bodies including the Steering Committee and subcommittees, IOTN working groups, and external scientific panels;
  • Manage these activities by organizing web-based conferences, taking minutes, and drafting reports for various committees, working groups, and panels. Develop, maintain, and make accessible all significant IOTN-related documents, including policies, reports, and standard operating procedures generated by the various IOTN committees, working groups, and panels;
  • Organize an annual IOTN consortium-wide grantees meeting. This meeting will have 50-100 attendees and take place in the Bethesda, MD, area. All attendees will support their own travel and lodging through their funded grants;
  • Manage or facilitate other IOTN activities, including but not limited to: organizing small topical workshops (All attendees will support their own travel and lodging through their funded grants); collaborations with outside groups; implementation of IOTN developed policies; and facilitating consortium opinion and perspective pieces;
  • Facilitate, as needed, interactions with other Cancer Moonshot-supported research efforts, other NCI and NIH supported efforts, and/or non-NIH partners. These may include consortia, bio-repositories, databases, or non-profit organizations involved in activities relevant to the mission of the IOTN. The focus should be on developing interactions that can benefit both investigators and partners of the IOTN through the sharing of information, expertise, and reagents, or through leveraging the coordination of research and technology development in areas of common interest.
  • Submit progress updates to the NCI as requested.

Sub-section B. DMRC - Resource-sharing and Scientific Outreach (RSO)

Address the anticipated activities of the RSO that include (but are not limited to):

  • Develop and maintain a Central IOTN Website that will constitute the main entry point for the sharing of resources and information related to IOTN activities;
  • Develop and implement user-friendly approaches to navigate and access resources generated by the IOTN, including protocols, data standards, tools and technologies, biospecimens and reagent information;
  • The Central IOTN Website should be accessible to a broad audience including patients, advocacy groups, the general public, and the larger scientific community;
  • The Central IOTN Website should include basic information about the Cancer Moonshot, the goals of the IOTN, members contact information, and the scope of the funded projects. This part of the website will prospectively house future achievements of the Consortium (e.g., publications, discoveries, hand-offs for clinical testing, etc.);
  • The Central IOTN Website should also feature a controlled access site that will serve the members of the IOTN for sharing privileged and sensitive information including patient data, preliminary data, pre-publication manuscripts, and other information not ready for public release;
  • Provide restricted access, internet-based resources such as mailing lists, wiki site, file sharing, or social media tools to share data and enable discussions within the IOTN consortium;
  • Develop or obtain and implement a Virtual Biorepository to oversee tracking and distribution of organ site-specific biospecimens, models, tools and technologies, and other resources;
  • The Virtual Biorepository will need to be structured in a way that allows for multiple levels of access, based on the level of confidentiality of the data, resource, or information being requested.
  • Develop training and outreach strategies to disseminate IOTN data, resources, and tools to the broader scientific community and;
  • Develop strategic plans to promote IOTN activities and resources to the larger scientific community that could include sponsoring sessions at scientific meetings, establishing discussion forums, or utilizing appropriate social media outlets.

Subsection C. DMRC - Data Integration and Sharing (DIS)

Address the anticipated activities of the DIS that include (but are not limited to):

  • Provide essential bioinformatics and computational support for the design, collection, management, and analysis of data (including genomic data, tumor targets, cellular analyses, and others) for all IOTN-funded components;
  • Deploy computational tools and support for IOTN studies relevant to neoantigen identification, T cell receptor profiling, and other immunogenomic analyses;
  • Enhance data management and sharing through optimization of data collection methodologies suitable for immune-related studies;
  • Work closely with IOTN PD(s)/PI(s) and NIH staff to establish common data elements, data standards, metadata requirements, controlled vocabularies, and quality control metrics for all IOTN data to ensure that the data are findable accessible, interoperable, and reusable (FAIR) to ensure the data and results are maximally useful to the public;
  • Facilitate data use by the broader scientific community by depositing all IOTN-generated datasets in appropriate unrestricted or controlled-access databases and develop a Data Portal (accessible through the Central IOTN Website) for user-friendly access to these databases that will constitute the main entry point for access to IOTN-generated data and linked databases;
  • Develop an Application Programming Interface (API) to facilitate interactions with other Cancer Moonshot Data Coordinating Centers, the Cancer Data Ecosystem, and/or other Cancer Moonshot Programs as specified;
  • Provide NCI staff with quantitative updates on data deposition, data quality, and data usage statistics upon request and;
  • Work closely with NIH staff and relevant public data/resource repositories to ensure the long-term archiving and distribution of IOTN datasets and resources beyond its funding period.

Sub-section D. Milestones and Timeline

In this section describe specific milestones and measurable goals/deliverables for the entire project. Identify a detailed project timeline. Milestones are intermediate steps towards the completion of concrete goals. The milestones must be well-defined to serve as appropriate objective performance targets. Yearly quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application in peer review and in consideration of funding of non-competing award years.

Specifically, address the following items:

  • Present measurable milestones as goals/benchmarks that will identify progress (or signal emergent difficulties); 
  • For each milestone, provide appropriately detailed (quantitative) criteria by which milestone achievement can be assessed and;
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal (use of a Gantt chart is strongly recommended).

The DMRC is also expected to evolve, adapt, and improve during the project in response to the needs of the IOTN community. DMRC applicants must demonstrate that their team will have the expertise and flexibility to accommodate increasing data volume and evolving data types.

Applicants should describe plans to improve the usability of the website by soliciting user feedback and/or analysis of usage (i.e., quantitation of page views). This plan should describe the frequency of these evaluations and how this information will be used to best serve the needs of the IOTN and broader research community.

Note: Reviewers will evaluate the quality, appropriateness, and rigor of the proposed milestones. To be considered for funding, applications must be viewed as strong in all these aspects.

Health Disparities: If applicable to the type of research being proposed, address how minority health or health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of minority health disparity 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 Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting Publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public and; (2) if applicable, provides a justification to NCI if such sharing is not possible. 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.

PHS Inclusion Enrollment Report

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

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.

It is anticipated that the terms of award will include, but not be limited to, the following:

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.

Investigators will be expected to:

  • Leverage, 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.
  • Coordinate with and leverage, 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 (The Next Generation Cancer Knowledge Network).
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 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 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.

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research consortium 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 consortium?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to their roles in the Center? 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 experience and an ongoing record of accomplishments in coordinating collaborative basic research? If the Center 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 Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed DMRC activities including bioinformatics expertise and the ability to partner and collaborate with other scientists or partnering organizations (e.g., academic laboratories, clinical sites and/or strategic partners)? Do DMRC PD(s)/PI(s) and key personnel/consultants demonstrate strong scientific expertise in immuno-oncology and prior experience in successfully managing a consortium?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium 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 applicant propose innovative plans (e.g., outreach strategies, data coordination solutions, use, and data analysis approaches for advancing the DMRC activities.  

Approach

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

Specific to this FOA: Are the methods for data coordination and information technology adequately developed, well-integrated, feasible and appropriate to support the specific activities of the DMRC? Are detailed plans to develop a Data Portal for controlled-access and/or unrestricted access (and user-friendly) to IOTN-generated data and linked databases provided? Are the proposed plans for a virtual repository for electronic tracking of models, tools, and other IOTN resources adequately described? Are strategies to disseminate IOTN data, resources, and tools to the broader scientific community addressed? Does the application contain acceptable plans for addressing the NCI Cancer Moonshot? Public Access and Data Sharing Policy?

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 children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the 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?

Specific to this FOA: How optimal are the applicant institution resources for supporting the goals of DMRC? To what extent will these environment(s) help respond to the needs of the IOTN?

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 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.

Inclusion of Women, Minorities, and Children 

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.

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:

  • 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 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 Advisory Council or Board. The following will be considered in making funding decisions:

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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.

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, 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 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 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 objectives and approaches, and to ensure scientific rigor in the planning, conducting, analyzing, and publishing of results, interpretations, and conclusions of studies conducted under this program;
  • Setting project timelines in consultation with NIH staff, and reporting progress and objectives to NIH staff;
  • Assuming accountability to the applicant organization officials and to the NIH IC Project Scientist for the performance and proper conduct of the research supported by the U01 award;
  • Coordinating efforts and cooperating with the other U01 and U24 components of the IOTN and with NIH Institute/Center (IC) Project Scientists. These actions may involve (but will not be limited to) participation in appropriate coordinating meetings and/or working groups, and/or teleconferences as needed;
  • Overseeing the implementation of an approved data sharing plan and resource sharing plan. Institutions/organizations participating in the Consortium will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the IOTN consortium;
  • 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);
  • Maintaining the confidentiality of the information shared by the IOTN consortium, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of the IOTN consortium, as well as any confidential information received by third party collaborators;
  • Annotating samples through the use of Consortium-defined Common Data Elements (CDEs).
  • Participating and presenting findings at annual grantee meetings convened by NIH IC Project Scientists through the DMRC;
  • Adhering to a Consortium Communication Plan: A consensus Communication Plan will be drafted by the Steering Committee during the Kickoff Meeting of the IOTN Consortium. This plan will clearly spell out interactive requirements that all IOTN Consortium PD(s)/PI(s) are expected to follow, including:
  • Participating in regular conference calls and contributing to various sub-committees and working groups;
  • Participating and presenting findings at IOTN annual investigator meetings; and
  • Coordinating efforts with other members of the IOTN consortium.
  • Meeting yearly timelines as defined by PD(s)/PI(s) and NIH IC Project Scientists at the time of award;
  • Working with, cooperatively interacting with, and actively seeking input from NIH IC Project Scientists;
  • Participating in NCI-coordinated evaluation of the IOTN program.

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. IOTN PD(s)/PI(s) are also encouraged to organize and participate in collaborative activities and scientific or programmatic working groups.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the NIH Project Scientists will monitor and evaluate progress toward meeting 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.

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

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. 

NIH IC Project Scientists will be responsible for:

  • Coordinating and facilitating interactions among the activities awarded under this initiative;
  • Working closely with investigators on research projects to coordinate and facilitate interactions/collaborations between U24 and U01 awardees across the consortium;
  • Assisting the awardees as a resource in facilitating their broader interactions with other NCI and NIH programs for the purpose of leveraging and coordinating existing NIH/NCI resources and infrastructures, such as those within the NCI ITCR program and the NCI Cancer Research Data Commons;
  • Assisting in avoiding unwarranted duplication of effort with other NCI efforts;
  • Monitoring institutional commitments and resources to the awardees;
  • Suggesting reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- specifically, the NIH IC Project Scientists may recommend withholding of support, suspension, or termination of an award for lack of adherence to required policies and/or procedures;
  • Developing working groups and trans-project efforts as needed;
  • Monitoring progress and direction of awardees and working groups as needed; and
  • Organizing and conducting regular meetings, as needed, to share progress between the U01 and U24 awardees of the IOTN Consortium either by teleconference, videoconference, or face-to-face interaction.

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 terminate this award in the event of:

(1) A substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application;

(2) A failure to meet the DMRC consortium policies and procedures;

(3) Substantive changes in the management of the DMRC award that are not in keeping with the objectives of the FOA; and/or

(4) failure to make substantial progress towards milestones keeping in mind the agreed upon go/no-go decisions.

Additional U24 Specific Responsibility include:

  • Meeting annually with other Moonshot U24 coordinating centers to establish a "Moonshot Community of U24 Communities" forum to learn about the overarching capabilities of other U24s; and
  • Coordinating, to the extent permitted, the standardization, harmonization and sharing of data and research resources, tools/platforms, including access to newly established biorepositories.

Areas of Joint Responsibility include:

A Steering Committee (SC) will serve as the main governing board of the program as described below.

Because a close interaction among the participating PD(s)/PI(s) and NIH staff will be required to develop consortium policies and meet Program goals, the SC will be the principal governing body of the IOTN. The awardee agrees to the role and authority of the SC for governance of IOTN consortium activities.

The SC will be composed of the following voting members:

  • One representative from each U01 project award (a PD/PI or their designee) who will have one vote;
  • One representative from each U24 (a PD/PI or their designee) who will have one vote;
  • A representative of a patient advocacy group who will have one total vote; and one NIH Project Scientist from each participating IC who will have one vote;
  • The remaining NIH IC Project Scientists will participate in SC meetings as non-voting members;
  • Additional NIH staff members, serving in an advisory capacity, may participate in these meetings as non-voting members; and
  • The Chair and co-Chair of the SC will be selected from the representatives of all awardees.

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

  • Attending monthly teleconference meetings;
  • Establishing IOTN consortium policies and procedures, guidelines and agreements;
  • Establishing policies and procedures for collaborative projects and protocols;
  • Developing guidelines for the collection and distribution of specimen reference sets for collaborative research;
  • Serving as a nucleus for a broader outreach to the entire extramural immuno-oncology research community;
  • Organizing agendas for annual Steering Committee meetings;
  • All major scientific and policy decisions will be determined by voting policies as established by the SC. Specific activities may include, but are not limited to:
  • Developing collaborative protocols;
  • Identifying impediments to success and developing strategies to overcome them;
  • Developing shared tools for disseminating information about the IOTN consortium;
  • Facilitating communication and fostering collaboration across the IOTN consortium;
  • Developing publication policies to facilitate collaborations and co-publications by consortium members; and
  • Ensuring that the IOTN consortium leverages existing NIH resources and programs;
  • NIH Project Scientists involved with the management of the IOTN will help the SC develop and draft sharing and operating policies that are in accordance with NIH guidelines;
  • The DMRC (U24) awardee PD(s)/PI(s) will be responsible for arranging annual grantee meetings at locations selected by the SC in consultation with the NCI; and
  • The SC may decide to establish sub-committees for specific purposes. The NIH IC Project Scientists will serve on such sub-committees, as they deem appropriate.

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 will be convened. The panel will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons 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

Scientific/Research Contact(s)

Kevin Howcroft, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6229
Email: Howcrofk@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: Crystal.wolfrey@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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