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

Mechanisms of Cancer Drug Resistance and Sensitivity: Coordinating Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-044

Companion Funding Opportunity
 
Number of Applications

An applicant institution may submit only one application in response to this FOA.  See Section III. 3. Additional Information on Eligibility.

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

 93.353, 93.395, 93.394 

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research.

The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating Center that will integrate and facilitate trans-disciplinary research across the Drug Resistance and Sensitivity Centers (DRSCs), established under an earlier released RFA-CA-17-009 for U54 specialized centers.

The DRSCs are designed to target the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): Establish a network of multi-disciplinary research teams to study mechanisms of tumor resistance and sensitivity and develop innovative anti-cancer therapy strategies.  The Coordinating Center to be established under this FOA will facilitate the activities of the DRSCs and help integrate the results of their studies.

Key Dates
Posted Date

October 20, 2017

Open Date (Earliest Submission Date)

December 5, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 5, 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.

No late applications will be accepted for this FOA

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

New Date June 2018 as per issuance of NOT-CA-18-019

Advisory Council Review
New Date August 2018 as per issuance of NOT-CA-18-019

Earliest Start Date
New Date September 2018 as per issuance of NOT-CA-18-019

Expiration Date

January 6, 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

The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating Center that will integrate and facilitate trans-disciplinary research across the Drug Resistance and Sensitivity Centers (DRSCs) U54s established under RFA-CA-17-009; and to the extent possible coordinate its activities with other Cancer Moonshot coordinating centers and NCI programs.  The DRSC U54s will conduct basic and preclinical research focused on investigating the mechanisms of tumor resistance (intrinsic or acquired) and sensitivity and on developing new therapeutic strategies that either combat tumor resistance or exploit its sensitivity. These strategies will explore genetic and other molecular characteristics of the cancer underlying sensitivity/resistance to anticancer treatments.

Each DRSC has 2-3 interrelated research projects. DRSC applicants have proposed collaborative arrangements (within one institution and/or with partnering institutions) to ensure all capabilities are met that might be necessary to fulfill the need for highly specialized multidisciplinary expertise.  The proposed projects have a clear translational potential to inform the development of novel therapeutic strategies based on mechanistic understanding of resistance and/or sensitivity to anticancer agents as mono or combination therapeutics.

Collectively, the DRSC U54s will act as a network (DRSN) with the U24 as its Coordinating Center to serve as a critical basic and preclinical part to NCI’s clinical therapeutics development. Basic and preclinical discoveries resulting from research performed by DRSCs should enable future clinical application of concepts to prevent and/or overcome cancer drug resistance within the NCI Cancer Therapy Evaluation Program (CTEP) clinical trials networks.  Applications that propose to conduct a clinical trial is beyond the scope of this FOA and of RFA-CA-17-009.

The U24 Coordinating Center will facilitate the DRSN activities, manage and harmonize data generated across the DRSN, and maximize the optimal utilization of resources within the network and - to the extent possible - with other Cancer Moonshot coordinating centers.  In collaboration with investigators across the NCI intramural program and the extramural Divisions portfolios, the U24 will also promote exchange of scientific findings and potential collaborations between the network investigator teams across the NCI portfolio, including NCI Precision Medicine Initiatives.  Formal meetings of the DSRN network participants, invited outside experts and Experimental Therapeutics Clinical Trials Network (ETCTN) investigators and trans-Divisional NCI extramural staff will be held twice each year, with at least one of these meetings being a face-to-face discussion at the NCI. 

The U24 Coordinating Center will also facilitate interactions between investigators at the U54 DRSCs and other NCI-funded resources/centers, including Frederick National Laboratory for Cancer Research (FNLCR) and its Pharmacodynamic Assay Development & Implementation Section (PADIS) laboratories staff.  The U24 Coordinating Center will also facilitate the access of CTEP IND investigational agents and use of the NCI formulary for basic and preclinical studies by the DRSN investigators.

Background

The DRSCs funded under “Mechanisms of Cancer Drug Resistance and Sensitivity" RFA-CA-17-009 were developed in response to the joint recommendation from the Pediatric Cancers and Tumor Evolution and Progression Working Groups of the National Cancer Institute (NCI) Moonshot Blue Ribbon Panel (BRP).  Each DRSC is based on 2-3 interrelated research projects that conduct basic and preclinical research focused on innovative strategies to understand and combat mechanisms of tumor resistance (intrinsic or acquired) and/or to exploit tumor sensitivity to anti-cancer therapies. These strategies explore genetic and other molecular characteristics of cancers' underlying sensitivity/ resistance to anticancer treatments. The specialized centers are pursuing distinct areas of cancer drug sensitivity and/or resistance research within the following disease platforms: acute myelogenous leukemia, multiple myeloma, non-small cell lung cancer, prostate cancer, colorectal cancer, and melanoma.

This FOA proposes to further implement this NCI BRP recommendation by adding a U24 Coordinating Center to help integrate and manage the activities of the DRSCs.  The DRSCs, together with the Coordinating Center will not only guide the development of the NCI’s Investigational New Drug (NCI-IND agents) portfolio through the NCI Experimental Therapeutics (NExT) program for single agents or combinations with genotoxic agents already in clinical trials (http://ctep.cancer.gov/protocolDevelopment/agents_drugs.htm), but also encourage the introduction of new therapeutics that may be under development but not yet part of ongoing NCI-sponsored programs.

Key Requirements of the DRSC Coordinating Center

The Coordinating Center will function as a crucial scientific and logistic infrastructure part of the DRSN.  The main responsibilities of the U24 will be to provide:

  • Logistical and administrative support and coordination of DRSN meetings and conferences;
  • Statistical support and computational analysis as needed by the DRSN; and
  • Data harmonization and management. 

The Coordinating Center must have expertise and capabilities in biostatistics, information technology, study design, data management, protocol development, and logistical support.

Areas under consideration for this Coordinating Center include expertise in:

A. Network support infrastructure.

  • Providing logistical and administrative assistance in arranging DRSN meetings, conference calls and workshops as needed;
  • Developing and maintaining an interactive web page to publicize DRSN and to announce the availability of DRSN-supported resources and receive input from investigators and research communities at large;
  • Developing and maintaining a "listserv" interactive email system for communication within the DRSN;
  • Assisting DRSCs in the preparation of milestones of achievement reports; and
  • facilitating contacts and interactions between DRSCs, NCI programs and ETCTN investigators to establish contacts and permit collaboration. 

B. Statistical support and computational analysis.  It is expected that, if needed, the U24 will have capabilities to support application of statistical and computational tools for the needs of the studies supported within the DRSN.  Areas of interest include, but are not limited to capabilities in: 

  • Developing and implementing standard procedures for data collection and common data elements considerations by the DRSN;
  • Developing instruction manuals for data collection from discovery work and interacting with the participating institutions to resolve data errors.  A significant portion of this support may require the creation of subset data files for statistical analysis and the generation of descriptive statistics through the use of existing analysis packages such as SAS.  These studies could require only one data collection per subject or might be longitudinal studies;
  • Assisting with statistical and computational support as needed by the DRSN;
  • Responding to requests from the NCI Program, designing interfacing modules with commercially available software necessary to support discovery related research activities.  An example of such software could be a generalized user-oriented interactive recode and statistical analysis system suitable for the analysis of high-dimensional data, e.g., microarray data from genomic, proteomic, or epigenomic studies.  Software designs developed by DRSCs will be implemented at the direction of the DRSN in coordination with NCI Program;
  • Preprocessing of high dimensional data deriving from proteomic-, genomic-, epigenomic-, and metabolomic-based assays; and
  • Developing/applying analytical tools for expression data analysis (from DNA, RNA, or protein array expression) with respect to clinical endpoints.

C. Data Management and Protocol Development.  The U24, as needed and under the direction of the DRSN and NCI Program will help:

  • Support the development, coordination, implementation, and conduct of potential DRSN collaborative research protocols;
  • Provide statistical analysis of DRSN collaborative studies;
  • Assist in preparing data analysis for manuscripts on DRSN collaborative studies;
  • Develop worksheets and information management systems for collection of data and specimen tracking in individual and multi-center DRSN studies, and verify all generated data deposited at the U24 Coordinating Center;
  • Assist in the collection of epidemiologic information, data analysis, study designs, quality assurance for a central database, statistical analyses of pooled data, and distribution of specimens stored at sites participating in the DRSN;
  • Develop uniform investigative protocols for data and specimen collection;
  • Support the formation and distribution of DRSN biospecimen sets and analyze data that result from the use of these specimens;
  • Develop and maintain a computerized data system for data management and statistical analysis;
  • Ensure that data are collected to determine the benefits and risks that follow from positive or negative test results;
  • Provide support services for the production of data forms and reports, graphics, and other materials as required;
  • Provide a mechanism for rapid and routine (to be decided by the DRSN in coordination with NCI Program) transmittal of materials (e.g., computer output, reports, etc.) among the DRSN participants and the NCI Program; and
  • Provide advice and consultation to DRSN investigators in study design and protocol development.

D. Coordination and sharing of resources with other Moonshot U24s.  The U24, under the direction of the DRSN and NCI Program will:

  • Meet annually with other Moonshot U24 coordinating centers to help coordinate the sharing of data, research resources, tools/platforms, and access to newly established biorepositories across the Moonshot initiatives.
  • Coordinate, to the extent permitted, the standardization, harmonization and sharing of data and research resources, tools/platforms, including access to newly established biorepositories.

Governance of the DRSN

The DRSN (i.e., DRSCs and Coordinating Center) will be governed by the DRSN Steering Committee. The DRSN Steering Committee will promote, in collaboration with other NCI program staff members, the exchange of scientific findings and potential collaborations between the investigator teams and NCI laboratories, as well as potential interactions between the investigators and members of NCI’s ETCTN and FNLCR.  Details on the composition and functions of the DRSN Steering Committee are provided in Section VI.2, Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions.

Evaluation of the DRSN

DRSN awardees will be expected to participate in an external evaluation process that will be coordinated by the NCI scientific staff.  This evaluation will largely be based on the overall progress towards achieving the scientific and NCI Moonshot goals of the DRSN program.  The evaluation will assess the quality and innovation of the research conducted by the DRSN, progress of the research projects, coordination and effectiveness of the collaborative activities (along the basic-preclinical-clinical spectrum) within the DRSN and outside the network - including other Cancer Moonshot and Precision Medicine initiatives, and overall ability to facilitate and implement the management of data, sharing of research resources 

NCI Resources to Support the Drug Resistance and Sensitivity Network

NCI will assist the DRSN by providing various additional resources.  For example, NCI will provide investigational agents in its IND agents portfolio for preclinical studies via a Material Transfer Agreement (MTA).  NCI investigators at the FNLCR may have available for study PDX models of relevant histology and genotype.  In some cases, patient bio-specimens acquired before and/or after drug treatment in NCI clinical trials may be available for study.  Biomarker assay procedures developed by the PADIS laboratories within the NCI Division of Cancer Treatment and Diagnosis (DCTD) may be of use as well.  The U24 Coordinating Center will facilitate entry of genomic and relevant clinical data from the project sites into the Genomic Data Commons (GDC) repository in order to share and extend molecular findings with databases and analytic tools within the GDC.

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 (1) Coordinating Center award, corresponding to a total of $500,000, for fiscal year 2018. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets must reflect the actual needs of the proposed project but must not exceed $350,000 per year in direct costs.

Award Project Period

 The total project period for an application submitted in response to this FOA 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 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
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.
  • 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:

Laurence (Austin) Doyle, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6112
Email: doylela@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.

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:  List Specific Aims for the proposed Coordinating Center

Research Strategy:  Instead of standard sub-sections, Research Strategy must consist of the following sub-sections A, B, C, D, and E.

Sub-section A. Overall Vision of the Proposed Coordinating Center

In this sub-section, address the following strategic goals:

  • Facilitating multi-institutional, trans-disciplinary research through scientific, administrative, and organizational support with emphasis on efficient communications, coordination of efforts, and trans-consortium and inter-institutional scientific collaborations (within the DRSN and between DRSN investigators and outside investigators);
  • Providing infrastructure to support the required administrative activities of such program, including, but not limited to, monitoring and coordinating the joint activities of all the participating sites, preparing required reports, addressing logistics, and preparing for group meetings, site visits, and outcome dissemination.

The description must include the following specific aspects:

  • The scientific vision of the proposed DRSN Coordinating Center;
  • Major strengths and critical experience of the research team particularly in coordinating multi-disciplinary and multi-institutional programs (explain collective strengths without repeating information in individual biosketches);
  • Innovative aspects of the Coordinating Center and its potential for coordinating the trans-disciplinary research conducted through the entire DRSN program;
  • Demonstrated level of competency in the coordinating the collection, analysis, harmonization and sharing of trans-disciplinary or multi-scale data expected to be generated by research conducted through the entire DRSN program;

Sub-section B. Logistical Support

Logistical support-related activities of the DRSN include, but are not limited to:

  • Monitoring and facilitating the activities of the DRSCs;
  • Preparing required reports; and
  • Addressing logistics, and preparing for various meetings, site visits, outcome dissemination, Steering Committee meetings, and periodic conference calls.

Sub-section C. Leadership and Administration Unit

In this sub-section, address the following strategic goals:

  • Facilitating the discussion and administrative support as needed of potential cross-DRSN collaborative projects;
  • Promoting and facilitating interactions between the DRSCs and NCI scientific staff to allow for efficient interactions, consultations, and oversight functions;
  • Providing logistical and administrative support for the activities of the DRSN Steering Committee and its subcommittee(s)/Working Groups;
  • Organizing the annual Steering Committee meeting (in collaboration with NCI project scientists) and periodic conference calls for the Research Centers;
  • Assisting the Steering Committee in assembling appropriate panels such as a subcommittee of experts to advise the Steering Committee;
  • Creating opportunities for disseminating research results across multiple venues.

The description must include the following specific aspects:

  • The organization of the leadership structure;
  • Plans for participation in the activities of the Steering Committee including workshops, conferences and other functions;
  • Plans for supporting data sharing among all DRSN participating sites as appropriate and consistent with achieving the goals of the program;
  • Plans for participation in administrative site visit conducted by NCI staff.

Sub-section D. Virtual Resource Repository Unit

In this sub-section, address the following strategic goals:

  • Establishing and operating a centralized data collection, management, analysis, and dissemination unit for the entire network to support this repository. This includes the capacity for setting-up a registry database that collects information on all available non-standard tools, reagents, protocols and technologies to be used in the DRSN program;
  • Track DRSCs' activities and accomplishments within the overarching goals of the NCI Moonshot initiatives of cross-utilization of unique research resources;
  • Establishing and operating a centralized data collection, management, analysis, and dissemination unit for the entire network to support a virtual biorepository that will function in accordance with the Guiding Principles for Cancer Moonshot Biobanking Activities (see Resource Sharing Plan section below and related documentation at http://biospecimens.cancer.gov/programs/cancermoonshot/principles and https://biospecimens.cancer.gov/bestpractices/). This includes the capacity for setting-up a registry database that collects clinical, demographic, and molecular information of patient samples to be used in the DRSN program, including information on the availability of biological specimens at all participating sites (including archived specimens). The biospecimen data must also include information about the regulatory approvals of specimen collections and the level of informed consent;
  • Establishing specimen and data access procedures that would allow for efficient sharing of specimens and data for collaborative research studies across the DRSN as well as with outside investigators as appropriate and consistent with achieving the goals of the program. The procedures should address the process for review and approval of applications submitted to access the specimens and/or data. The procedures should also describe the tracking and distribution of available specimens to investigators, consistent with achieving the goals of the program.

The description must also include the following specific aspects:

  • Plans for creating a patient registry with virtual biorepository that will collect and assemble clinical, demographic, and molecular information of all patient materials (including archived specimens);
  • Plans for collecting information about the availability of biological specimens at all the DRSN participating sites, including information about the regulatory approvals of specimen collections and the level of informed consent;
  • An access mechanism that will facilitate the sharing and distribution of information and biospecimens across the DRSN program for collaborative research studies (between DRSCs and between DRSN investigators and non-DRSN investigators) as appropriate and consistent with achieving the goals of the program.

Sub-section E. Health Disparities Unit

If applicable to the type of research being proposed, address how 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 racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Addressing the Cancer Moonshot Public Access 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; (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.

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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

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

For NCI-relevant CDEs, please visit CDE (Common Data Element) Browser: https://www.nlm.nih.gov/cde/

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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

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

Specific to this FOA: Are the available research infrastructure, programs, and scientific expertise adequate to support the DRSC research centers?

Investigator(s)

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

Specific to this FOA: Does the applicant team have experience overseeing selection and management of sub-awards, if needed?  

Innovation

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 management strategies proposed?   

Specific to this FOA: Does the application propose novel organizational concepts in coordinating the DRSN research network the Coordinating Center will serve?

Approach

Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Is an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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?

Specific to this FOA: Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the DRSN research network, as appropriate for the work proposed?

Leadership and Administration Unit

Are the research infrastructure, programs, and collaborations adequate to support the DRSN Research Centers? Is there adequate evidence for the managerial and collaborative capabilities of the proposed Coordinating Center leadership? How appropriate is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of the DRSN program; (b) the coordination of multiple institutions participating in the DRSN Research Centers; and (c) understanding and familiarity with the state of the science in this field of research? Will the Coordinating Center have the appropriate capabilities to support proposed projects and data sharing among all DRSN participating sites? How adequate are the plans to achieve compatibility with the DRSN Research Centers to facilitate data and resource sharing across the DRSN Research Network? Does the administration infrastructure demonstrate the capacity of the DRSN Coordinating Center to collaborate with the DRSN Research Centers and NCI program staff on scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships?

Virtual Resource Repository Unit

How appropriate and balanced are the proposed plans to create the Virtual Resource Repository? Does the Coordinating Center have the capacity for setting-up a database that collects information on all available non-standard tools, reagents, protocols and technologies, along with clinical, demographic, and molecular information of all patients samples to be used in the studies conducted by the DRSN program, including information on the availability of biological specimens at all participating sites? Are the plans well justified and include appropriate safeguards for privacy and confidentiality protections of identifiable data? Does the plan describe a program that will efficiently support the sharing of unique tools, technologies, specimens and information across the DRSN as well as access by extramural collaborating investigators as appropriate and consistent with achieving the goals of the program? Does the plan enable the tracking and distribution of available non-standard materials, protocols, technologies, reagents and new and/or archived specimens to investigators, consistent with achieving the goals of the program?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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

  • Determining the Coordinating Center's scientific directions and its goals;
  • Determining and coordinating research approaches and procedures for the collection and analyses of research and specimen data from the DRSN Research Centers;
  • Facilitating the organization of DSRN annual meetings, working groups and teleconferences as needed;
  • Providing scientific and technical assistance and advice to the awardees as appropriate, serving as scientific collaborators when appropriate;
  • Assist in avoiding unwarranted duplication efforts with other projects funded within the DSRN;
  • Overseeing the timely release and sharing of specimens and data from the program according to the approved plans;
  • Participating in the development and evaluation of cross-DRSN and with NCI and non-DRSN collaborations;
  • Participating in the annual DRSN Steering Committee meeting, and periodic conferences organized by the DRSN Coordinating Center;
  • Accepting and implementing all scientific and practical decisions approved by the DRSN Steering Committee to the extent consistent with applicable grant regulations;
  • 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).
  • In addition to standard annual Research Performance Progress Report (RPPR) submissions, supplying additional progress-related information; and
  • Preparing for administrative site visits by NCI staff members.
  • Meeting annually with other Moonshot U24 coordinating centers to help coordinate the sharing of data, research resources, tools/platforms, and access to newly established biorepositories across the Moonshot initiatives.

The following additional responsibilities will also apply for the Coordinating Center awardee:

  • The Coordinating Center and the entire DRSN program will be subject to periodic performance evaluation (coordinated by the DRSN Steering Committee Chair) and external evaluation (coordinated by the NCI). DRSN Awardees will be expected to participate in such evaluations;
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies;
  • The Coordinating Center will be encouraged to share with the DRSN program knowledge, specimens, data, research materials, and any other resources as appropriate.

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

An NCI Program staff member(s) acting as a Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement.

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators).

The specific roles of the substantially involved NCI staff members include the following activities:

  • Serving as the NCI lead Project Scientists and voting members of the DRSN Steering Committee;
  • Assisting in avoiding unwarranted duplications of effort across the DRSN program;
  • Helping coordinate collaborative research efforts that involve multiple Research Centers;
  • Monitoring the operations of the DRSN Research Centers and make recommendations on overall project directions and allocations of funds;
  • Reviewing the progress of individual Research Centers and specific activities shared among the Research Centers and Coordinating Center;
  • Participating in the development and evaluation of cross-DRSN Projects;
  • Co-organizing and participating in the annual DRSN Steering Committee meeting;
  • Collaborating with the DRSN investigators in some shared research activities, if appropriate;
  • Assisting the DRSN awardees as a liaison in stimulating their broader interactions with other NCI and NIH programs to disseminate results and outcomes and effectively leverage existing NIH/NCI resources and infrastructures;
  • Evaluating the adherence of DRSN awardees to the approved data and resource sharing plans.
  • 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. 

Areas of Joint Responsibilities include:

The DRSN Steering Committee will serve as the main governing board of the DRSN program.

  • The committee will consist of the following voting members:
  • ·    The PD(s)PI(s) of each awarded Research Center who will collectively have one vote;
  • ·    The PD/PI of the Coordinating Center and a designated senior investigator who will collectively have one vote; and
  • ·    The NCI Project Scientists who will collectively have one vote for the NCI.
  • The DRSN Steering Committee will meet at least one time per year in a face-to-face meeting. A chair of the DRSN Steering Committee will be selected at the first meeting to coordinate the committee's operation. The DRSN Steering Committee chair will meet by teleconference with NCI Project Scientists as needed to address program issues.
  • Additional non-voting members who can serve in an advisory capacity may be added to the DRSN Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies.

The DRSN Steering Committee will have the following primary responsibilities:

  • Oversee the overall DRSN program and review its research progress;
  • Review the potential of shared support infrastructure(s) at individual Research Centers to serve the needs of other Research Centers and the entire program;
  • Develop procedures for soliciting and evaluating ideas for pilot projects across the DRSN as well as criteria for their prioritization and approval;
  • Ensure that the Research Centers and the Coordinating Center take advantage of existing NCI and NIH resources and programs;
  • Make recommendation for termination of projects that become unpromising or unproductive;
  • Participate in the development of the agenda for the annual Steering Committee meeting to present scientific progress and future plans from DRSN investigators.
  • Establish advisory groups as necessary to ensure the progress of individual Research Centers as well as of the entire DRSN program.
  • Ensure that individual DRSN members (i.e., Research Centers and Coordinating Center) accept and implement as appropriate actions (recommendations, directions, etc.) approved by the DRSN Steering Committee.

Dispute Resolution:

  • Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons 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)

Laurence (Austin) Doyle, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6112
Email: doylela@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)

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