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

Molecular and Cellular Characterization of Screen-Detected Lesions - Coordinating Center and Data Management Group (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • July 11, 2014 - See Notice NOT-CA-14-051. Notice of Pre-application Teleconference for RFA-CA-14-010 and RFA-CA-14-011 for The "Molecular and Cellular Characterization of Screen-Detected Lesions" Initiative
Funding Opportunity Announcement (FOA) Number

RFA-CA-14-011

Companion Funding Opportunity

RFA-CA-14-010, U01 Research Project – Cooperative Agreements

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

 93.393, 93.394, 93.396 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits U01 applications for a Coordination and Data Management Group (CDMG) as a component of a Consortium to conduct biological analysis of screen-detected, interval-detected, and symptom-detected Cancers.  The Consortium will have independent, multi-disciplinary teams to undertake a comprehensive molecular and cellular characterization of tumor tissue, cell, and microenvironment components to distinguish screen-detected early lesions from interval and symptom-detected cancers.  Individual research teams will pursue one or more aspects of molecular and cellular analysis of one or more of the specified tumor sites (breast, prostate, lung, melanoma, and pancreas).  Use of enabling approaches and technologies will be encouraged to determine both the cellular and molecular phenotypes of early lesions, to assess the degree to which the behavior of these lesions is predictable or stochastic, and to allow better predictions of the fate of early lesions.  To achieve the goal of a comprehensive characterization of screen-detected lesions, each research team should include cancer researchers and clinicians with multi-disciplinary expertise.  The funded individual research teams are expected to participate in a collaborative Consortium.  In addition to individual studies, a major collaborative effort within Consortium will be the establishment of an annotated biospecimen repository of screen-detected lesions and interval cancers.  Research teams will also be expected to share results freely within Consortium, and to develop trans-Consortium collaborative projects that make use of the combined expertise and technological capabilities present in all of the teams.

The responsibilities of the CDMG will be: (1) coordination of consortium-wide meetings and conferences, and collaborative activities; (2) statistical support and computational analysis; and 3) data management and protocol development for the biorepository.

Key Dates
Posted Date

June 6, 2014

Open Date (Earliest Submission Date)

August 17, 2014

Letter of Intent Due Date(s)

August 17, 2014

Application Due Date(s)

September 17, 2014, by 5:00 PM local time of applicant organization.

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

January-February 2015

Advisory Council Review

May 2015

Earliest Start Date

July 2015

Expiration Date

September 18, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the 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.


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

A critical unmet need in the management of malignancies (e.g., breast, prostate, lung, and pancreas cancer, and melanoma) are minimally invasive methods that predict whether a screen-detected lesion is indolent, requiring only careful monitoring, or progressive, thus requiring appropriate intervention.  The goal of this initiative is to achieve a comprehensive cellular and molecular characterization of early lesions, including the tumor cell and its microenvironment, and to identify features that distinguish indolent from aggressive and/or progressive lesions.

This Funding Opportunity Announcement (FOA) solicits applications from independent, multi-disciplinary teams to undertake a comprehensive characterization of tumor cell and microenvironment components of screen-detected early cancers, interval-detected cancers, and symptom-detected cancers.  The development of such studies will depend on: 1) establishing a biorepository (from existing or new collections), in which specimen annotation includes whether the lesion was detected by screening or due to symptomatic clinical presentation; and 2) determining and distinguishing molecular and cellular characteristics of screen-detected lesions and/or surrounding tissue environment compared with interval-detected and symptom-detected cancers.

Individual research teams will pursue one or more aspects of cellular or molecular analysis of one or more of the specified tumor sites (breast, prostate, lung, melanoma, and pancreas).  Use of enabling approaches and technologies (e.g., genomics, epigenomics, proteomics, imaging, single cell analyses, laser capture micro-dissection, and patient-derived xenografts) will be encouraged to determine both the cellular and molecular phenotypes of cancer and stromal cells, to assess the degree to which the behavior of these early lesions is predictable or stochastic, and to allow better predictions of the fate of early lesions. 

To achieve the goal of a comprehensive characterization of screen-detected lesions, each research team should include cancer biologists (with expertise in molecular and cellular characterizations), clinicians, pathologists, imagers, statisticians (as appropriate), and epidemiologists (as appropriate).  The individual research teams funded through this FOA are expected to participate in a collaborative Consortium.  In addition to individual studies, a major collaborative effort will be the establishment of an annotated biospecimen repository of screen-detected lesions and interval cancers.  Research teams will also be expected to share results freely within Consortium, and to develop trans-Consortium collaborative projects that make use of the combined expertise and technological capabilities present in all of the programs.  In the final selection of the programs to be funded under this initiative, the NCI will, if possible, attempt to ensure that most of the specified tumor sites are represented.

Consortium Goals and Structure

The teams funded by the Consortium will be expected to participate in collaborative efforts in the planning and development of resources and reagents necessary for the characterization of screen-detected lesions that will be made available to the broader research community.  Collaborative arrangements with other Federal and State programs, supporting autopsy-based sample collections, are also anticipated through interagency agreements.  Examples of collaborative efforts to be undertaken by the Consortium may include establishing repositories and generating and distributing novel reagents such as stromal markers and cell lines, or the development of novel technologies that distinguish indolent from progressive lesions.  Collaborations with other NCI Programs [e.g., Early Detection Research Network (EDRN; www.cancer.gov/edrn), Tumor Microenvironment Network (TMEN; http://tmen.nci.nih.gov), Breast Cancer Surveillance Consortium (BCSC; http://breastscreening.cancer.gov), Prostate, Lung, Colorectal and Ovary Screening Trial (PLCO; www.plcostars.com), Population-based Research Optimizing Screening through Personalized Regimens (PROSPR; http://appliedresearch.cancer.gov/networks/prospr) are highly encouraged.

The initiative funded by the companion FOA (RFA-CA-14-010) is intended to support a network of approximately eight to ten multi-disciplinary, multi-institutional research teams (Molecular Characterization Laboratories; MCLs).  Each team will receive funding for research projects, as described above.  Additional funds in the form of administrative supplements may be provided to support collaborative projects developed within the Consortium.  Such an infrastructure is intended to provide a novel and essential venue to facilitate interdisciplinary collaborations and progress, and to make information on molecular and cellular characteristics of early lesions accessible to the broader research community.

The core members of the Consortium will be the investigators funded via this initiative, but may be expanded to include investigators already supported by other mechanisms (e.g., R01s and P01s, NIH intramural investigators).  Through the Consortium, the individual research teams and thereby the investigators, will have access to resources, information, technologies, ideas, and expertise that are beyond the scope of any single research team.  Individual teams funded through this initiative will operate independently, but will be linked through a central focus on characterizing screen-detected early lesions, a common bioinformatics infrastructure, a shared repository of screen-detected and interval lesions, and a Steering Committee.  For this purpose, a Coordination and Data Management Group (CDMG) will also be established.  CDMG will work with MCL teams to ensure that future data are collected according to established protocols and Standard Operating Procedures (SOPs), Common Data Elements (CDEs), etc.  NCI staff will provide oversight and manage Consortium activities.

In addition to the establishment of standards for data collection on specimens, subject accruals, and clinical attributes, a coherent and comprehensive strategy is expected for study design for the discovery of intra- and inter-cellular molecular interactions and metabolic pathways relevant to screening.  The Steering Committee of the Consortium will have the responsibility for the scientific management and oversight of all Consortium activities. The details on the SC are provided in Section VI. 2. Cooperative Agreement Terms and Conditions.

Specific Research Objectives and Requirements

The goal of this FOA is to establish a Coordination and Data Management Group (CDMG) as a  crucial scientific part of the Consortium.  It is essential that CDMG applicants familiarize themselves with the companion FOA for the Molecular Characterization Laboratory component of Consortium (MCL; RFA-CA-14-010) with which the CDMG must work.  The main responsibilities of the CDMG will be to provide: (1) logistical support and coordination of Consortium-wide meetings and conferences; (2) statistical support and computational analysis as needed by the other components of Consortium; and 3) data management and protocol development.  The CDMG must have expertise and capabilities in biostatistics, information technology, study design, data management, protocol development, and logistical support.  Qualified investigators in the CDMG should assume responsibility in a flexible manner as scientific research and study design needs arise.

1. Network Coordination.  The CDMG will:

  • Provide logistical and administrative assistance in arranging meetings of the SC, and the Executive Committee of the SC (e.g., preparing, distributing and maintaining minutes of meetings) – there will be two face-to-face Steering Committee Meetings per year, and monthly Executive Committee conference calls;
  • Provide logistical and administrative assistance in arranging workshops as needed;
  • Provide other operational support for the Consortium (e.g., communications, subcommittee meetings, telephone conference calls);
  • Produce and maintain all documents, including Manual of Operations and procedures manuals;
  • Develop and maintain an interactive web page to publicize Consortium and to announce the availability of Consortium-supported resources and receive input from investigators;
  • Develop and maintain a "listserv" interactive email system for communication within the Consortium; and
  • Work with the NCI Program Coordinators on the review of applications/proposals submitted to the Consortium Steering Committee.

2. Statistical support and computational analysis.  It is expected that the CDMG will support application of statistical and computational tools for the needs of the studies supported within Consortium.  Areas of interest include, but are not limited to: 

  • Develop and implement standard procedures for data collection by the Consortium MCLs.
  • Develop instruction manuals for data collection from discovery work and interact 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.
  • Develop programs to assist with or provide the following: screening of prognostic factors, survival analysis and curve graphing, covariate modeling of survival, descriptive statistics, least-squares regression analysis, power and sample size calculations, table making, data sub-setting, two variable scatter plots and analysis of time dependent covariates.
  • In response to requests from the NCI Program Coordinator, design 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 CDMG will be implemented at the direction of the Consortium SC.
  • Support other statistical services for the Consortium as directed by the Consortium SC.
  • Preprocessing of high dimensional data deriving from proteomic-, genomic-, epigenomic-, and metabolomic-based assays.
  • Development/application of analytical tools for analyzing expression data (from DNA, RNA, or protein array expression) with respect to clinical endpoints.
  • Development/application of analytical software to extract novel information from in silico data, relevant for sub-classification of screen-detected or symptom-detected cancers into indolent versus aggressive/progressive lesions.

3. Data Management and Protocol Development.  The CDMG, under the direction of the Steering Committee will:

  • Support the development, coordination, implementation, and conduct of Consortium collaborative research protocols;
  • Provide statistical analysis of Consortium collaborative studies;
  • Assist in preparing data analysis for manuscripts on Consortium collaborative studies;
  • Develop worksheets and information management systems for collection of data and specimen tracking in individual and multi-center Consortium studies, and verify all generated data deposited at the CDMG;
  • Monitor Consortium protocol adherence, monitor data collection and submission, and report violations to the Steering Committee;
  • 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 Consortium;
  • Develop uniform investigative protocols for data and specimen collection;
  • Support the formation and distribution of Consortium 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 Steering Committee) transmittal of materials (e.g., computer output, reports, etc.) among the Consortium participants and the NCI Program Coordinators and other NCI staff; and
  • Provide advice and consultation to Consortium investigators in study design and protocol development of Consortium-collaborative studies, after the study has been approved by the Consortium Steering Committee.
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.

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 commit $500,000 in FY 2015 to fund one award.

Award Budget

Application budgets are limited to $300,000 in direct cost per year reflecting the actual needs of the proposed project.

Award Project Period

The project period is limited to 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
  • 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.

NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Sudhir Srivastava, Ph.D., M.P.H.
Chief, Cancer Biomarkers Research Group
Division of Cancer Prevention
National Cancer Institute
9609 Medical Center Drive, Room 5E136, MSC 9790
Bethesda, MD 20892-9790 (for USPS Regular or Express delivery)
Rockville, MD 20850 (for non-USPS delivery)
Telephone: 240-276-7028
Fax: 240-276-7845
Email: srivasts@mail.nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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 or Modular Budget

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

a) The contact PD/PI must include a minimum of 1.8 person months of his/her time per year and all other PDs/PIs (if multiple) must include a minimum of 1.2 person months of their time per year to the award. This commitment cannot be reduced in later years of the award.

b) Applicants must budget for travel and per diem expenses for Steering Committee meetings.  In the first year, applicants should plan for the PD/PI and an additional senior investigator to attend a Planning Meeting and two Steering Committee meetings.  In the second and subsequent years, applicants should plan for the PD/PI and another investigator to attend two Steering Committee meetings per year.

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: Applicants must outline the scope of the proposed research and its relevance to a specific unmet clinical need in the management of human malignancies.  The specific aims to be pursued and approach(s) to be employed must be also described in brief.

Research Strategy: Specific Sub-Sections A-B that must be included in Research Strategy are described below.  

The responsibilities of the Consortium CDMG are diverse. Each of the responsibilities described in the section "Section I. Funding Opportunity Description” is relevant to the overall performance of the Consortium.

Sub-section A. Investigators Capabilities and Experience

Outline the major strengths and collective capabilities of the leadership and the team in the areas of:

  • Statistical, mathematical, and computational biology as relevant to research on cancer and technologies used in cancer detection, diagnosis, and prognosis;
  • Management of large-scale collaborative research efforts involving multiple institutions;
  • Ability to ensure meaningful contribution to such activities as protocol design, data entry procedures, manual preparations, data collection, and data quality control;
  • Logistical services and organizational support that have been utilized in managing resources and monitoring performance in previous large-scale, collaborative research; and
  • Accomplishments in the development of statistical and computational tools and demonstrable research expertise in managing projects relevant to cancer detection, diagnosis and prognosis.

Sub-section B. Plans for the Required Areas of Responsibility

Applicants must describe in detail the development, implementation, and maintenance plans for each required area of responsibility (defined in Section I. Research Objectives of this FOA).  These main areas of responsibility include:

  • Consortium Coordination;
  • Data Management and Protocol Development; and
  • Statistical and computational analysis support.

In particular, address the following aspects:

  • The ability of the proposed CDMG to contribute unique expertise, capabilities, and/or resources to the entire Consortium;
  • Your approach on how CDMG may contribute to collaborations, sharing information, and working towards the priorities and goals agreed upon by the Steering Committee for trans-Consortium collaborative studies;
  • Anticipated needs of research projects (to be conducted by the MCLs) for statistical/analytical tools for study design, data analysis, and interpretation;
  • How the structure and activities planned for the CDMG will be matched to these needs and the anticipated trans-Consortium activities; and
  • Approach to ensure flexibility and facilitate implementation, if needed,  of statistical and/or analytical approaches beyond those specified in the application.

These plans should include description of design, personnel requirements, and infrastructure (hardware, software, other).  Applicants are encouraged to describe in their application the cost-efficient use of existing technologies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review and responsiveness by the NCI, NIH.  Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

In addition, specific to this FOA: How well do the proposed theoretical and applied research projects address an important need for statistical/analytical tools for study design, data analysis, and interpretation? Over the project period, is there potential for the applicant to develop statistical and analytical approaches other than those specified in the application? Are the structure and activities planned for the CDMG adequate for the needs of the studies to be conducted by the MCLs and the anticipated trans-Consortium activities? How likely is the proposed CDMG to contribute unique expertise, capabilities, and/or resources to the entire Consortium?

Investigator(s)   

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

In addition, specific to this FOA: Are the PD/PI and his/her collaborators appropriately trained and productive in the area of statistical, mathematical, and computational biology? Will this team of investigators contribute unique skills to the overall objectives of Consortium? Is the commitment of the PD(s)/PI(s) and other senior investigators adequate for the work proposed? To what degree, does the applicant team take advantage of a collaborative and interactive model of research? How likely are the applicants to engage in collaborations, sharing information, and work towards the priorities and goals agreed upon by the Steering Committee for trans-Consortium collaborative studies?  Are the PD/PI and support personnel adequately trained and qualified for participating and managing multi-institutional collaboration?

Innovation

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

In addition, specific to this FOA: Does the proposed approach/methodology challenge existing paradigms or develop new computational/statistical approaches?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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? 

In addition, specific to this FOA: Does the application adequately address how each of the goals set for the three required areas of responsibility will be accomplished? Are relevant technical problems and their timely and effective solutions adequately addressed? Are the conceptual framework, design, methods, and analyses adequately developed and appropriate to the aims of the proposed research? Are the planned activities sufficiently trans-disciplinary and scientifically well integrated? Does the applicant acknowledge potential problem areas and consider alternative approaches? Will the proposed approaches be generally applicable to statistical analysis of data related to the systematic analysis and classification of cancers identified by different modes of detection or between indolent and aggressively progressing cancers?

Environment

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

In addition, specific to this FOA: Are facilities and equipment for data storage, data security, and data analysis appropriate to efficiently support the required tasks of Consortium coordination, data management and protocol development, and statistical and computational analyses?  Has the applicant demonstrated adequacy of proposed infrastructure and commitment and documented evidence of institutional support for proposed endeavor and institutional support for computer services?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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) Genome Wide Association Studies (GWAS).

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

The PD/PI (or multiple PDs/PIs, if applicable) under the Consortium auspices will have primary responsibilities in the following areas:

  • Defining objectives and approaches, overseeing planning and conducting experiments, analyzing and interpreting results, and publishing reports of studies conducted under this award.

  • Assuming responsibility and accountability to the applicant organization and to the NCI for the performance and proper conduct of the research in accordance with the terms and conditions of the award.

  • Serving as voting members of the Consortium Steering Committee (the PD/PI and another senior investigator from each Consortium award (made under RFA-CA-14-010 and RFA-CA-14-011) will be required to attend Steering Committee meetings twice a year).

  • Accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee to the extent consistent with applicable grant regulations;

  • Coordinating efforts and cooperating with the other components of the Consortium and with NCI staff Members;

  • Overseeing the implementation of the approved data sharing plan;

  • Ensuring that experimental data and their format, analytical algorithms, computational modeling and visualizations, and other bioinformatics tools resulting from this FOA are compatible with the NIH-approved bioinformatics platforms, such as those designed and implemented by the NCI Center for Bioinformatics (http://cbiit.nci.nih.gov).

  • The PDs/PIs and their awardee institutions will be accountable for implementing the approved research resource sharing plan.

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

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

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

Designated NCI Program Directors serving as Project Scientists/Coordinators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Main NCI responsibilities include the following:

  • Coordinating and facilitating various activities of the Consortium programs;

  • Participating in the activities of the Consortium Steering Committee;

  • Serving as a liaison between the Steering Committee, the Consortium awardees, and the NIH;

  • The NCI Project Coordinator(s), in cooperation with the NCI Center for Bioinformatics, will ensure that there are effective mechanisms to enable electronic communication among the Consortium components, and between the Consortium and the NCI;

  • Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action;

  • Assisting the investigators in avoiding unwarranted duplications of effort across the Consortium;

  • Co-organizing and participating in the Consortium investigators meetings;

  • Monitoring the scientific progress of individual Consortium awards and the entire program;

  • Reviewing the compliance of Consortium awardees with the recommendations developed by the Steering Committee; and coordinating external evaluation of the Consortium.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those Consortium awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

The substantially involved NCI Project Scientist/Coordinators will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications.  If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  A Program Official may also have substantial programmatic involvement (as Project Scientist/Coordinator).  In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

Areas of Joint Responsibility include:
Steering Committee: The Steering Committee will be the main governing body for the Consortium, as defined below.

The Consortium Steering Committee will consist of the following voting members:

Two representatives from each Consortium  award (the PD(s)/PI(s) or a PD/PI and a designated senior investigator) who will have one vote each; and

The two NCI Project Scientist/Coordinators (who will have one vote each for the NCI).

Additional NIH staff members may participate in Steering Committee meetings as non-voting members as needed (for example to provide additional expertise).  The non-voting members may include representatives from NCI extramural divisions and a representative from the National Cancer Institute Center for Bioinformatics and Information Technology (NCI CBIIT).

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

In addition, the chairs of each of the EDRN and TMEN programs or their designees will serve on the Consortium Steering Committee as ex officio members.

The Steering Committee will meet twice every year, at locations selected by the Steering Committee in consultation with the NCI.

Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.

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

The Steering Committee will have primary responsibility for:

Setting the overall research priorities for the Consortium; and identifying emerging research opportunities which can be best explored through a joint collaborative effort via the Consortium;

Serving as a nucleus for a broader outreach to the entire extramural research community investigating indolent versus aggressive cancers or cancers detected via existing screening programs or based on the appearance of clinical symptoms;

Optimizing the information flow among the funded programs and between the programs and NCI CBIIT, i.e., it will provide a central conduit for information dissemination to other NCI-funded programs and to the cancer research community; and

Promoting efforts to establish new reagents, methodologies, and/or experimental models to be shared among the Consortium members and with the research community at-large.

Joint Consortium Activities

A significant part of the Consortium will be Joint Consortium activities. The Consortium will: provide an appropriate venue for close interactions among investigators; facilitate exchange of data and comparison of results obtained across a variety of tumors; and disseminate expertise that may be initially concentrated within a single awardee group.  The NCI will ensure common access to Consortium-generated resources and reagents for the broader cancer research community.  The NCI will also encourage the Consortium members to interact with existing NCI-supported multidisciplinary teams, such as the Early Detection Research Network (EDRN), and the Integrated Cancer Biology Program (ICBP).

To facilitate communications among the participants in the Consortium and between the Consortium and the NCI, the NCI will establish and maintain an Internet-based information technology solution for rapid data and document transmission and electronic communications for the Consortium.

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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

For questions about the CDMG as well as those related more to cancer prevention research, contact:

Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7028
Email: srivasts@mail.nih.gov

For questions about the CDMG as well as those related more to cancer biology research, contact:

Suresh Mohla, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6220
Email: mohlas@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@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 Parts 74 and 92.

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