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

Cancer Immunologic Data Commons (CIDC) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-006

Companion Funding Opportunity

RFA-CA-17-005, U24 Resource-Related Research Projects – Cooperative Agreements

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

93.394, 93.395 

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications for establishment of a Cancer Immunologic Data Commons (CIDC) to provide bioinformatics support as part of a Network for correlative studies in clinical trials involving cancer immunotherapy. The Network will encompass a single CIDC award (to be supported by this FOA) and up to three Cancer Immune Monitoring and Analysis Centers (CIMACs) (to be supported by a companion FOA, RFA-CA-17-005).  

The goal of the CIMACs-CIDC Network is to enable systematic incorporation of biomarker studies in NCI-supported early clinical trials for immunotherapy.  CIMACs will be responsible for comprehensive analyses of biospecimens from patients for biomarkers relevant to genomic, phenotypic, and functional aspects of responses to immunotherapy. CIDC will serve the bioinformatics needs of the Network, including collection, integration, access, and analysis of data generated from CIMACs.  The CIDC will also contribute to the long-term goal of creating publically accessible Data Commons for cancer immune profiling as well as clinical data that will allow integrated analysis across trials and access by the larger immuno-oncology research community.

Specifically, the CIDC will be expected to:

Adopt or develop data collection standards and database modules for key assay platforms for tumor- and immune-profiling.  This will be done in collaboration with CIMACs.

Establish database for collection and management of biomarker and associated clinical data generated from CIMACs.

Provide and maintain bioinformatics tools for data access and multi-dimensional analysis within and across trials in the CIMACs.

Facilitate regulated data sharing and access by outside investigators and research community, as appropriate and consistent with achieving the goals of the program.

The long term goal of the CIMACs-CIDC Network is to develop molecular signatures that define immune response categories to correlate with the clinical outcomes of immunotherapy in cancer. Collectively, the outcome of the Network research should lead to the identification of biomarkers with a translational potential for optimizing the therapeutic strategies for patients.  

Key Dates

 

Posted Date

December 16, 2016

Open Date (Earliest Submission Date)

New Date: February 17, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

New Date: March 17, 2017, 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 Funding Opportunity Announcement.

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

May-June 2017

Advisory Council Review

August 2017

Earliest Start Date

September 2017

Expiration Date

New Date March 18, 2017 per issuance of NOT-CA-17-020. (Original Expiration Date: March 4, 2017)

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 to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
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) solicits applications for Cancer Immunologic Data Commons (CIDC), which will provide the informatics support for Cancer Immune Monitoring and Analysis Centers (CIMACs) (to be supported by the companion FOA, RFA-CA-17-005), in the CIMACs-CIDC Network.  Together, the CIMACs and the CIDC will be the primary units of the CIMACs-CIDC Network. CIMACs-CIDC Network is intended to serve as infrastructure for correlative studies in NCI-sponsored clinical trials involving cancer immunotherapy to address the critical importance of biomarkers in management of cancer patients.

Specifically, the Network is intended to address scientific and technical aspects of correlative studies across the NCI-supported early Phase (1 and 2) clinical trials in immunotherapy. CIMACs will provide a wide range of molecular and cell-based biomarker analyses. The long term goals are to identify molecular biomarkers that define immune response categories to: (1) predict the likelihood of benefit or toxicity from therapies; (2) help develop rational combination therapies to overcome intrinsic or acquired resistance; (3) aid in understanding resistance mechanisms; (4) provide monitoring strategies; and (5) evaluate target inhibition via pharmacodynamic biomarkers.

The CIDC will be expected to establish and manage the data repository for biomarkers and associated clinical data for CIMACs, and provide an informatics environment for integrative multi-dimensional analysis across different studies and storage of data generated.  The CIDC should also enhance data sharing through standardization of data collection methodologies and use of metadata standards suitable for immune-related biomarkers, and integration with other existing biomarker and clinical databases. An important additional goal for CIDC is building a foundation that would allow for the evolution of the Data Commons in the future (i.e., after the CIDC award period) into a sustainable immuno-oncology data resource serving the larger cancer research and clinical communities.

Through these collaborative efforts, CIMACs-CIDC Network is expected to accelerate the integration and translation of important research findings generated by individual laboratories in clinically-based studies into applications to enhance efficacy of immunotherapy to benefit patients.

Background 

Immunotherapies-promises and challenges. Immunotherapies have emerged as highly promising approaches to treat cancer patients. Several checkpoint inhibitors have demonstrated remarkable clinical benefit in several indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma and bladder cancer. However, the clinical efficacy is limited to a minority of cancer patients.  Further development of immunotherapy to broaden the therapeutic potential for more patients requires better understanding of the tumor-immune interface at the cellular and molecular level and an ability to select the specific agent or combination regimen for given patients. Translational studies with strong focus on biomarkers are critical to investigations in both areas.

Critical role of biomarkers in optimizing immunotherapeutic strategies. Various experimental findings point to the value of biomarkers for predicting benefit of therapy and understanding the mechanisms of resistance. For example, high tumor expression of PD-L1 is predictive of increased likelihood of clinical benefit from anti-PD-1 therapy in patients with NSCLC. Other factors associated with response included high mutational load, inflammatory gene signatures, and tumor infiltrating lymphocytes. More recently, tumor genomic studies in patients treated with checkpoint inhibitors revealed mutations in interferon response pathway genes as the potential mechanisms of primary or acquired resistance.

Whereas these findings are promising, systematic incorporation of biomarkers in studies involving more patients is needed for validation of the preliminary findings and development of new markers.  Optimized biomarker strategies have the potential to reveal the mechanisms of response and resistance to therapies, provide guidance for combination strategies and identify predictive markers for benefit or toxicities.

NCI efforts in clinical development and translational research for immunotherapy. NCI funding of various programs have collectively supported a large portfolio of immunotherapy trials.  For example, since 2000, the Division of Cancer Treatment and Diagnosis (DCTD) has sponsored more than 90 immunotherapy clinical trials through the DCTD clinical trial networks, including Phase 1 trials to randomized Phase 2 and Phase 3 trials.  Many immunotherapy agents and their combinations are being studied, including agents targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), programmed cell death protein 1(PD-1) and PD-1 ligand (PD-L1), CCR4, CD27 as well as bispecific antibodies, oncolytic viruses, cancer vaccines and cytokines. 

The NCI-supported clinical trial networks represent a valuable setting to incorporate and address important biomarker questions.  Importantly, most trials have mandatory collection of 'baseline' tissue and blood and many Phase 1-2 trials also mandate 'on-treatment' biopsies.  However, although numerous technologies for tumor and immune profiling are applied, the assay protocols and data reporting procedures are not standardized, hampering data integration and meaningful comparisons across studies. In addition, most of the assays involving high-throughput multi-parametric signatures require significant statistical and bioinformatics efforts for algorithm development and data interpretation. Such capabilities are not readily available to all investigators.  Furthermore, there is no standing system that can easily integrate analyses across NCI-supported clinical trials. 

To address the issues noted above, the NCI proposes to establish a Network of laboratories (Cancer Immune Monitoring and Analysis Centers, CIMACs) and a biomarker data storage/access platform (Cancer Immunologic Data Commons, CIDC) (this FOA), to enable systematic incorporation of biomarker studies associated with NCI-supported clinical trials involving immunotherapy.  The CIDC will provide the bioinformatics support for the CIMACs-CIDC Network.  The established Data Commons will also be expected to provide the foundation for a future immuno-oncology data resource for the larger research community. 

Main Objectives and Key Requirements for the Cancer Immunologic Data Commons (CIDC)

Proposed CIDC for the Network must include the following main attributes (for additional details, please see Section IV.2 Content and Form of Application Submission).

Overall Focus of the CIDC

The Cancer Immunologic Data Commons (CIDC) supported by this FOA, RFA-CA-17-006, together with Cancer Immune Monitoring and Analysis Centers (CIMACs) (to be supported by the companion FOA, RFA-CA-17-005) will be main units of the CIMACs-CIDC Network. The overall goals for the Network is to advance translational research efforts using biomarkers to aid in the further development of cancer immunotherapy.

Whereas CIMACs will function primarily as laboratory platforms for the Network, CIMACs will also include biostatistics and computational functions and will collaborate with the CIDC on various aspects of data processing and integration. Since CIDC will be required to interact closely with CIMACs, it is imperative that CIDC applicants familiarize themselves with CIMAC RFA-CA-17-005.

The CIDC will be expected to establish a biomarker data repository for the results generated by CIMACs. Therefore, CIDC must be able to work closely with each CIMAC on standardization of data collection methods, data transfer, access, and integration across different studies. CIDC will be expected to provide the informatics tools for integration with other accessible databases (e.g., clinical, immunology or genomic databases), with the goal of enabling high dimensional, integrative, correlative analyses across trials in the Network. CIDC database should be designed and implemented to facilitate data contribution and secondary analyses by outside research communities.

CIDC’s Expectations and Requirements.

The CIDC will have an important role in integrating the scientific efforts and ensure coordination across individual CIMACs. The CIDC must be able to provide adequate information technology infrastructure and the essential bioinformatics expertise for collection and management of biomarker data from CIMACs and provide an environment for integration with other databases or knowledge services that are necessary for integrative and correlative analysis. The CIDC will also provide administrative and logistic support for the Network.

The CIDC will establish a common database and data sharing environment for published and non-published biomarkers and associated clinical data, and provide informatics tools for controlled, role-based access to data for integrative and correlative analysis. The established Data Commons will serve the need of CIMACs-based biomarker studies, but will also be expected to provide the foundation for a future immuno-oncology data resource for the larger research community (beyond the scope of this FOA). Important Note: Applications that are particularly strong in terms of addressing the goal of planning for and preparing the CIDC for the future role as a research community resource may receive a programmatic priority in selection for funding.

CIDC - Bioinformatics Functions:

Collection of correlative data sets from individual trials generated in CIMACs will be integrated to create models of complex molecular and cellular interactions and generate signatures for tumor and host immunity interaction in the context of response to immunotherapy. The CIDC will be responsible for building a centralized resource based upon common data standards and contributing to the creation of an immunoprofiling database for broader dissemination to the immuno-oncology community.

Specifically, the CIDC will be expected to provide essential data coordination for the entire CIMACs-CIDC Network through the development of a web- and application programming interface (API)-based data management system that provides standardized tools for biomarker data collection and access across projects carried out by CIMACs.

  • The CIDC will work with CIMACs for standardization of data collection methods;
  • The CIDC will establish the data repository for biomarker assay data generated from the CIMACs. The types of biomarker data will include, but are not limited to: tumor genomics, immunogenomics, phenotypic and functional characterization of T cells and the tumor microenvironment. (This data repository function should be established and be fully operational, at least for high priority biomarker modules, within the first year of award in order to support the CIMACs activities);
  • The CIDC will provide an informatics environment that enables integrative and correlative analysis; and
  • The CIDC is also expected to provide scientific input to biomarker study design upon request.

CIDC - Administrative Functions:

The CIDC will work closely with the Laboratory Coordinating Committee (LCC) that will serve as the Governance body for the CIMACs-CIDC Network to coordinate efforts and to promote synergistic research efforts:

  • Establishment and maintenance of a controlled-access website for the Network to provide information about the resources available within the Network;
  • Development of a web resource for rapid data exchange and electronic communication across the Network;
  • Logistical and administrative assistance in arranging Network-wide meetings and workshops involving CIMACs and the LCC that will govern the overall activities of the Network;
  • Coordinating Network activities across all CIMACs, CIDC and LCC, including collaborations with outside groups; and
  • Administrative management of service requests for the correlative studies from clinical trials outside the NCI clinical trials networks/consortia.

CIMACs-CIDC Network Governance:

The CIMACs-CIDC Network will be governed by a Laboratory Coordinating Committee (LCC). Details on the composition and functions of LCC are provided in Section VI.2 Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions.

External Evaluation of the CIMACs Network

CIMACs 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 goals of the entire CIMACs-CIDC Network Program.

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

The NCI intends to fund a single Cancer Immunologic Data Commons (CIDC) award, corresponding to $650, 000 in direct costs in fiscal year 2017.

Award Budget

Budget is limited to no more than $650K in direct costs for any budget year.

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:

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
  • 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 not allowed.

Required Registrations

Applicant Organizations

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

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

  • System for Award Management (SAM) (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:

Helen Chen, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: helen.chen@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities and Other Resources:

Describe the infrastructure and resources that will be available to CIDC, including specifically the documentaion of resources relevant to the goal of CIDC and database infrastructure with regard to attributes such as capacities, robustness, scalability and queriability.

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. Additional guidance applies.

The budget should address the following FOA-specific items:

  • PD/PI Effort Commitment. Any PD/PI (whether designated as contact or not) must commit a minimum of 1.2 person-months effort per year to the award.  This commitment cannot be reduced in later years of the award. Note that this is a minimum effort level that should be increased as appropriate to meet the needs of the work.
  • The budget request should account for the efforts of bioinformatician(s), computer/data base experts, and other information technology personnel to be involved in data collection and processing in the CIDC. The effort levels should be well justified in the context of the CIDC needs.
  • The budget request may include the costs of additional computational hardware, software and data storage upgrade costs if necessary to meet the needs of CIDC. However, such upgrade items must be well justified and their combined costs must not exceed $35,000 in any year of project period. Capital equipment (i.e., with unit cost over $5,000) is not allowed.
  • Travel Funds. The budget should include travel funds for PD(s)/PI(s) and other senior investigators (up to three people) to attend the annual Network and LCC meetings and for a Technical Lead and/or Project Manager to interface with the CIMAC leads on data/standards requirements. Applicants may also request modest funds for senior CIDC personnel for travel associated with interactions with CIMACs.
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 the Specific Aims for the proposed CIDC along with key strategic milestones.

Research Strategy: 

Describe the proposed CIDC using the FOA-specific sub-sections as defined below:

Sub-section A. Overall Vision of CIDC. Explain how the CIDC will facilitate the efforts the CIMACs-CIDC Network by providing informatics infrastructure and organizational support. The description should include the following specific aspects:

  • Explanation of priorities, feasibility, key milestones, etc., in terms of advancing the overarching goals of the CIMACs-CIDC Network;
  • General organizational framework and strategy for coordinating the activities across the network;
  • Level of readiness and strategies to implement the informatics resources that will be required for CIDC to properly serve the network;
  • Strategy to engage CIMACs in the implementation of uniform approaches to standardization of molecular profiling data to enable data sharing among CIMACs, as appropriate and consistent with achieving the goals of the program;
  • Highlights of any innovative aspects of the proposed CIDC;
  • The strategic ways to maximize the potential of the CIDC in advancing the field of immunotherapy (during the CIDC award period and beyond);
  • Future Transition of CIDC into research community Data Commons resource: Under a separate heading, present your vision on how CIDC may evolve in the future (beyond the scope of the CIDC award) and, specifically, transition into a sustainable immuno-oncology resource for research and clinical communities. Indicate concrete steps that may/should be taken during the project period. Using analogy to other similar resources (e.g., the NCI Genomics Data Commons), consider addressing such aspects as those listed below:
  • Anticipated general strategies to provide access to all curated data from CIMACs for sharing with the larger immuno-oncology community and anticipated needs for resource usage;
  • How the infrastructure, team expertise, etc., to be established by the CIDC may be used as a foundation for Data Commons serving the role of a research resource; and 
  • Resource architecture that might encompass storage and computing infrastructure, co-location of data (genomic, non-genomic markers, clinical data, etc.), and commonly used tools for analyzing and sharing.

Sub-Section (B) Scientific and Technical Capabilities:

Address the following specific aspects, emphasizing the collective abilities (without repeating information from individual biosketches):

  • Summarize the major collective strengths of the team and the experiences that will be vital for the proposed CIDC;
  • Explain the team collective capabilities and expertise in database management of immune biomarkers and integration with other databases, as required for multidimensional analysis;
  • Illustrate the leadership capability for coordinating complex analyses of immune markers, which will be required for collaboration among the CIMACs’ biostatistics and computational components;
  • Summarize the level of proficiency of the team in managing the complex intellectual property issues, including those involving clinical trials conducted with pharmaceutical partners;
  • If the proposed CIDC will involve partnering institutions and/or multiple, geographically spread facilities, explain how the efforts will be coordinated and integrated.
  • Without repeating information from Facilities & Other Resources, explain the strengths of your technical capabilities including information technology and bioinformatics hardware, software, and other tools. Address such aspects as:
  • Ability to accept raw data files;
  • Capacity of the systems to support the large file uploads and robust performance for computationally intensive simultaneous data analyses;
  • Scalability of the system for potential expansion; and
  • Queriable database and environment for dissemination for the broader immuno-oncology research community.

Sub-section C. Informatics Infrastructure and Bioinformatics Support Functions of CIDC: Provide details on how the proposed CIDC will provide the informatics support, infrastructure, etc., to implement efficient data collection/data access environment serving biomarker studies across CIMACs. Address the following specific items, discussing such aspects as availability of specific infrastructures or functions (or their development/adaptation/updates/).

  • Plans for establishing/adapting standards for data elements and formats that will be used for data collection protocols for various data types for key tumor- and immune-profiling platforms. Data types to consider should include those used for genomic, phenotypic or functional characterization of the host immune system and tumor microenvironment.   Examples of high priority assay platforms that are likely to be used by CIMACs can be found in the companion FOA (RFA-CA-16-005, Section I, under "Main Objectives and Key Requirements").  The plans should ensure that the CIDC will be able to handle data types generated by all such platforms, including, but not limited to, the following:
  • Protein profiling based primarily on multiplex assays;
  • Transcriptional profiling;
  • Functional characterization of immune responses; and
  • Genomic characterizations (DNA and RNA sequencing, genotyping, etc.).
  • Plans to establish a centralized repository to house biomarker data generated from CIMACs.  The repository should be established, at least for high priority biomarker modules, within the first year of award in order to support the CIMACs activity.  The required data types will be selected in conjunction with CIMACs, and should include key tumor and immune profiling platforms.
  • Plans for establishing a data access platform and interface that can integrate multiple biomarker modules as well as clinical data, to facilitate multi-dimensional and integrative analysis within and across trials;   
  • Plan for alignment and integration with data platforms and modules from the outside research community, where appropriate;
  • Plans for establishing a role-based access and compartmentation strategy for data access by CIMACs members, with the provision that access may also be provided to qualified external investigators. 
  • Plans for coordination with other NCI data platforms (e.g., NCI Genomic Data Commons, https://gdc.cancer.gov/) or non-NCI biomedical data platforms to provide access to CIMACs-generated data; and
  • Other bioinformatics resources and/or strategies proposed to support the Bioinformatics Functions of the CIDC.

Crucial Milestones and Timelines. Also in this Sub-section C (under a separate sub-heading) describe milestones and provide timelines for the development of specific key elements (a Gantt chart may be used). Include clearly the "strategic level" milestones relevant to key expectations for CIDC such as:

  • Standardization of data formats with CIMACs;
  • Development of Data Base and interfaces for data transfers between each CIMAC and CIDC.   (which should be operational by the end of the 1st year of award).   
  • Development/adaptation/implementation of bioinformatics tools, cross-analyses capabilities, etc.

Milestones must include clear and objective criteria for accomplishing a specific goal. If qualitative milestones are proposed (e.g., " fully operational system status"), they should be defined also in terms of achieving specific technical (and/or quantitative) parameters.  Investigators should:

  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal;
  • Include milestones to be accomplished in the first year that cover at least Data Modeling, Systems Design, Systems Development, Integration, Testing, Deployment, and Security Review & Systems Activation for CIMAC network;
  • Identify any impediments that could require modification of the research plan, milestones, or timeline with a discussion of alternative approaches.

Sub-section (D) Administrative Unit:

In this sub-section, address the organization and roles of Administrative Unit, including the following aspects:

  • Logistical and administrative assistance to the Network (arranging Network-wide meetings, workshops etc.);
  • Logistical support to the LCC activities (e.g., organization of the meetings in collaboration with NCI, periodic conference calls for CIMACs and CIDC etc.) as needed;
  • Administrative management of the CIMACs service requests from the NCI-supported research grant awardees (outside the NCI clinical trials networks/consortia) for evaluation by the LCC; and
  • Plans for a website for the CIMACs-CIDC Network to enhance collaborations among the CIMACs and to distribute information about the resources available within the CIMACs.

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.
  • Data Sharing Plan is expected to adhere to the guidelines in the NCI Genomic Data Sharing Policy (https://www.cancer.gov/grants-training/grants-management/nci-policies/genomic-data).
  • A software dissemination plan, with appropriate timelines, is expected to be included in the application. The plan should address the following:
  • The software (including bioinformatics tools) should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  • The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
  • The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues.
  • To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application for funding may include a plan to incorporate the enhancements into the core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Accordingly, awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system such as GitHub.

Prior to funding, NCI program staff members may negotiate modifications of data sharing plans with the applicant. Any data sharing plans represent a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of any accepted data sharing plans will become a condition of the award.

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 NCI, 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 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 Center address the needs of the CIMACs-CIDC Network that it will coordinate? Is the scope of activities proposed for the CIDC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the CIMACs-CIDC Network?

Specific for this FOA: How well does the proposed CIDC address the database needs for effective biomarker studies and data sharing across CIMACs? Is there sufficient bioinformatics infrastructure to support the proposed activities? 

Investigator(s)

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

Specific for this FOA: How strong are the expertise and competencies of key personnel in the areas of information technology and biomedical data acquisition, processing, and integration? Are these qualities sufficient to ensure the system/resource design that can be easily expanded in the future (beyond the project period) to serve as a research data resource to external investigators?  Are levels of effort of such personnel adequate to all the needs?

Innovation

Does the application propose novel, effective organizational concepts or management strategies, in coordinating the research of CIMACs that the CIDC 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 or management strategies proposed?   

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the CIMAC research that the CIDC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the CIMACs-CIDC Network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are there appropriate plans 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 for this FOA: Will the CIDC (as proposed) have all the requisite capabilities, infrastructures, resources, etc. for setting-up an appropriate informatics system that will integrate all expected data types? Once the system is fully established, how strong will be its support for multi-dimensional correlative analyses? How appropriate are the plans for establishing the Data Commons in terms of scope and timeline proposed?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the CIMACs-CIDC Network/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?

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 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. A programmatic priority may be given to applications that are particularly strong in terms of addressing the goal of planning for and preparing the CIDC for the future role as a research community Data Commons resource.
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.

Final Data Sharing Plan: Prior to funding, NCI program staff members may negotiate modifications of data sharing plans with the applicant. Any data sharing plans represent a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of any accepted data sharing plans will become a condition of the award.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

  • Determining the CIDC directions, coordinating scientific approaches and procedures, and overseeing the analyses and interpretation of analysis data;
  • Overseeing the timely release and sharing of data according to the approved plans;
  • Providing logistical support to Network Laboratory Coordinating Committee (LCC);
  • Participating in the annual LCC meetings, and periodic conference calls organized by the LCC;
  • Cooperating with NCI Project Scientists and clinicians in the program, as needed;
  • Accepting and implementing all scientific and practical decisions approved by the LCC to the extent consistent with applicable grant regulations;
  • Providing information to the NCI Program Directors concerning progress by submitting annual progress reports;
  • Preparing for administrative site visits by NCI staff members; and
  • Taking advantage of opportunities to collaborate with CIMACs to advance the Center research effort.

In addition, the awardees must ensure that all the activities under CIDC award are consistent with the following rules and regulations:

  • Research projects using biospecimens from NCI/CTEP clinical trials are subject to the requirements in NIH policies for data sharing and public access to publications, listed below, and to any applicable requirements of binding collaborative agreements. 
  • If the biospecimens are from a clinical trial that was conducted under a binding collaborative agreement with NCI or a pharmaceutical company (for example, with a company that supplied the drug), data sharing may have to await the timelines stipulated in those agreements.  Studies conducted under a NCI/CTEP IND are subject to the terms of the CTEP IP Option (http://ctep.cancer.gov/industryCollaborations2/guidelines_for_collaboration.htm) as well as the terms of the CTEP Collaborative Agreement under which the study is conducted.  Similarly, studies conducted under a NCTN Group or Company IND will also be subject to the terms of the agreement between the Collaborators.  Any discoveries from research performed on such specimens will be subject to the CTEP IP Option and/or the licensing terms as required by these agreements.

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

The designated NCI Program staff members of the Laboratory Coordinating Committee (LCC) will have substantial involvement as Project Scientists in the awards under this FOA. The specific roles of the substantially involved NCI staff members include the following activities:

  • Serving as members of the LCC;
  • Helping coordinate collaborative research efforts and assisting in avoiding unwarranted duplications of effort across the Network;
  • Monitoring the operations of the Centers and making recommendations on overall project directions; this activity shall include on-site visits to the Centers;
  • Reviewing the progress of individual Centers and specific activities shared among the Centers and CIDC;
  • Participating in the development and evaluation of cross-Network activities;
  • Co-organizing and participating in the annual LCC meetings;
  • Assisting the Network 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 (e.g., databases); and
  • Assisting awardees in implementation of requisite quality control/quality assurance measures.

In addition, CTEP (in conjunction with other relevant NCI Programs) will be substantially involved in optimizing the usage of CIMACs-CIDC network, including balancing the needs and programmatic priorities for the NCI-supported clinical networks (i.e., the primary clinical partners CIMACs-CIDC Network) versus the requests for biospecimen analyses/correlative studies from other (non-network) NCI-supported clinical trials. In this context, NCI Project Scientists will be in charge of:

  • Negotiating with each CIMAC recipient the optimal alignment with specific NCI-funded clinical networks, considering optimized usage of scientific and technical capabilities of each CIMAC and the goal of assuring coverage of all NCI-supported early phase immunotherapy trials in NCI networks;
  • Reviewing and approving the activation of clinical and correlative studies associated with the assigned primary clinical partners (i.e. the NCI-supported clinical trial networks); and
  • Reviewing the LLC recommendations regarding the prioritized correlative studies for clinical trials protocols associated with the requests other (non-network) NCI-supported clinical trials and approving the protocols for such correlative studies for activation by CIMACs.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. Such an individual may also be substantially involved as a Project Scientist.

Areas of Joint Responsibilities include:

The CIMACs Network Laboratory Coordinating Committee (LCC) will serve as the main governing board of the CIMACs-CIDC Network. The LCC will consist of the following voting members:

  • The PD(s)PI(s) of each awarded CIMAC (or a PD/PI and a designated senior investigator) who will collectively have one vote for each CIMAC;
  • The PDs/PIs of the CIDC (or a PD/PI and a designated senior investigator) who will collectively have one vote for CIDC; and
  • The NCI Project Scientists, who will represent three relevant NCI programs (Cancer Therapy Evaluation Program, Cancer Diagnosis Program, and Biostatistical Research Program) and who will collectively have one vote for the NCI.

A chair of the LCC will be selected at the first LCC meeting from the CIMACs-CIDC representatives (the LCC chair cannot be an NIH representative.)

The LCC will meet at least once a year in a face-to-face meeting and as needed by teleconferences. (These meetings and other LCC activities will be logistically supported by CIDC.)

LCC may invite additional individuals as non-voting members, as needed, e.g., serve in an advisory capacity. These additional members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies.

LCC will have the following primary responsibilities:

  • Overseeing the overall Network program and reviewing its research progress;
  • Evaluating and prioritizing all clinical protocols and correlative studies associated with the requests from outside the primary partners of the CIMACs and making recommendations to CTEP regarding activation of high priority correlative studies protocols and their assignment to specific CIMACs;
  • Developing procedures for soliciting and evaluating ideas to analytically validate biomarker assays across the Network as well as criteria for their prioritization and approval;
  • Making recommendations for termination of analyses that become unpromising or unproductive;
  • Developing the agenda for the annual LCC and Network investigator meetings; and
  • Making other recommendations, as appropriate, for specific actions, e.g., procedure standardization, to be adapted by the Network and/or individual awardees.

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 progress report, 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: 301-710-0267

Scientific/Research Contact(s)

For general inquiries regarding this FOA:

Magdalena Thurin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5973
Email: thurinm@mail.nih.gov

For inquiries regarding Data standards, Data management, IT infrastructure, Software architecture and Informatics

David Patton
National Cancer Institute (NCI)
Telephone: 240-276-5177
Email: david.patton@nih.gov

For inquiries regarding the NCI-supported Clinical Trials Networks and Consortia:

Helen Chen, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: helen.chen@nih.gov

For inquiries regarding other "non-network" NCI-supported immunotherapy clinical trials:

Minkyung (Min) Song, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6139
Email: songm@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)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@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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