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

Physical Sciences-Oncology Network (PS-ON): Physical Sciences-Oncology Centers (PS-OC) (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-169

Companion Funding Opportunity

NOT-CA-14-039

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.393, 93.394, 93.395, 93.396, 93.399  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites U54 cooperative agreement applications for Physical Science-Oncology Centers (PS-OCs). The PS-OCs will serve as hubs for the collaborative Physical Sciences-Oncology Network (PS-ON). The goal of the PS-OC Program and broader Network is to promote a physical sciences perspective of cancer and foster the convergence of physical science and cancer research by, forming transdisciplinary teams of physical scientists (e.g., engineers, chemists, computer scientists, mathematicians, physicists) and cancer researchers (e.g., cancer biologists, oncologists, pathologists) to work closely together to advance our understanding of cancer biology and oncology. The PS-OCs, individually and as a Network, will support transdisciplinary research that: (1) establishes a physical sciences perspective within the cancer research community; (2) facilitates team science and field convergence at the intersection of physical sciences and cancer research; and (3) collectively tests physical sciences-based experimental and theoretical concepts of cancer and promotes innovative solutions to address outstanding questions in cancer research.  

Key Dates
Posted Date

April 1, 2014

Open Date (Earliest Submission Date)

May 9, 2014

Letter of Intent Due Date(s)

May 9, 2014; January 15, 2015; October 14, 2015

Application Due Date(s)

June 9, 2014; February 26, 2015; November 25, 2015, 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)
 
Scientific Merit Review

August/September 2014; May/June 2015; February/March 2016

Advisory Council Review

January 2015; August 2015; May 2016

Earliest Start Date

April 2015; September 2015; July 2016

Expiration Date

November 26, 2015

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this funding opportunity announcement (FOA) is to build a cadre of Physical Science-Oncology Centers (PS-OCs, or Centers) to serve as hubs for the collaborative Physical Sciences-Oncology Network (PS-ON, or Network). The PS-OCs will conduct transdisciplinary research integrating the perspectives of physical scientists (e.g., engineers, chemists, computer scientists, mathematicians, physicists) and cancer researchers (e.g., cancer biologists, oncologists, pathologists) to study cancer using approaches and theories from the physical sciences. The PS-OCs are expected to assemble and develop transdisciplinary teams, research and training programs, and infrastructure organized around a physical sciences-based framework to address fundamental questions in cancer research. These transdisciplinary Centers will develop and test, individually and through collaborative Network activities, physical sciences-based experimental and theoretical concepts that complement and advance our current understanding of cancer biology and oncology. The initiative is expected to further develop emerging fields of study in cancer research that are based on physical sciences principles and approaches.

The Network will include both the PS-OCs and the Physical Sciences-Oncology Projects (PS-OPs, or Projects) U01s that will be invited through a companion FOA. The PS-OCs will serve as hubs for the Network and address more complex and challenging questions that require a broader range of expertise and multiple integrated projects. The PS-OPs will provide opportunities for investigators or smaller teams with the necessary transdisciplinary expertise to address specific, focused questions. Investigators from both the PS-OCs and PS-OPs will be expected to collaborate and share data and expertise across the Network and participate in Network activities and annual meetings.

The aim of the PS-ON is to integrate physical sciences perspectives into cancer research to complement and expand on our current understanding of cancer across many length-scales and time-scales, with the ultimate goal of improving cancer prevention, detection, diagnosis, prognosis, and therapy.

Background

In 2008, the National Cancer Institute (NCI) convened a series of strategic Think Tanks to investigate approaches to more effectively engage the physical sciences in cancer research. Think Tank participants identified a number of scientific areas where physical sciences perspectives could inform cancer research and concluded that integrated transdisciplinary teams were best suited to overcoming the traditional barriers and silos that have separated these two scientific communities. In the fall of 2009, the NCI launched the PS-OC Program, a Network of 12 Centers investigating complex and challenging questions in cancer research from a physical sciences perspective. The original PS-OC program made a number of exciting discoveries and made steady progress towards its scientific and programmatic goals.

To explore how the NCI can continue to strategically support the integration of physical sciences and cancer research, a Think Tank and series of Strategic Workshops were held in 2012 to examine the progress of the PS-OC Program and to identify areas that required continued or additional support. These workshops brought together experts from the fields of physical sciences, engineering, mathematics, cancer biology, clinical oncology, developmental biology, and others, with approximately 75% of participants from outside of the PS-OC Program. The workshops served to update the challenges and opportunities at the interface of physical sciences and cancer research and refine the thematic areas and fundamental questions that would benefit from an integrated transdisciplinary approach. Information from these workshops helped shape the scientific and structural elements of the ongoing PS-ON.

Research Objectives

The aim of the PS-OC program is to integrate physical sciences and cancer research perspectives and approaches to address complex and challenging questions in cancer research. The Think Tanks and Strategic Workshops held in 2008 and 2012 identified a number of areas where physical sciences perspectives could impact and advance cancer research. While this FOA invites a broad range of research that addresses important cancer questions from a physical sciences perspective, two example areas of interest are described below. Applicants may focus on one of these example thematic areas, other physical sciences-based thematic areas, such as the role of evolutionary theory in cancer or de-convoluting the complexity of cancer, or integrate multiple thematic areas.

Potential areas of investigation include but are not limited to:

The Physical Dynamics of Cancer: Traditionally, cancer is thought of primarily as a genetic disease that is modulated by biochemical cues from the tumor and microenvironment. However, physical properties across many length-scales (e.g., subcellular, cell, tissue, organ, whole organism) also play an important but poorly understood role. This physical perspective can be integrated with the molecular and genetic understanding of cancer to generate a more comprehensive view of the complex and dynamic multiscale interactions of the tumor-host system. Physical properties such as mechanical cues, transport phenomena, bioelectric signals, and thermal fluctuations can modulate the behavior of cancer cells, the microenvironment, tumors, and the host. In developmental biology, studying how these physical factors regulate embryogenesis and tissue patterning has augmented existing approaches and knowledge. Techniques from the physical sciences can be used to measure physical properties of single-cells, discrete multicellular structures, and tissues. These measurements can be integrated with orthogonal data using high-dimensional analysis and computational physics models to complement current approaches and potentially identify new physical properties that could be exploited for cancer prevention, detection, diagnosis, prognosis, and therapy. Potential questions to be addressed include, but are not limited to:

Spatio-Temporal Organization and Information Transfer in Cancer: Appropriate spatial and temporal organization of structures across many length scales (e.g., subcellular, cell, tissue, organ, whole organism) and time scales is required for managing the transfer of information that is critical for regulated growth. For example, cells must position billions of molecules in the right place and time to facilitate the proper function of signaling pathways and complexes. Additionally, cells regulate the size, number, and spatial distribution of organelles, and the three-dimensional architecture of the genome and nucleus. Intrinsic and extrinsic factors in turn regulate the size, shape, and heterogeneity of tissues. Metastasis occurs on a system level and the dispersion and dissemination of tumor cells depends in part on the architecture of both primary and metastatic sites. Disruption of spatial and temporal organization at each of these scales is associated with the development and progression of cancer and may influence the evoultion of therapeutic resistance. Techniques and perspectives from the physical sciences are particularly well-suited to exploring the complexity of these multiscale processes. For instance, advanced imaging and analysis techniques facilitate measurements at length scales ranging from subcellular to tissue-level with a high degree of spatial and temporal precision. These data can be complemented using tissue mimetics or three-dimensional tissue engineering tools; and, computational physics models or evolutionary theories can be used to integrate data across scales and iteratively inform subsequent studies. Potential questions to be addressed include, but are not limited to:

Organization of Individual PS-OCs and the PS-ON

PS-OC Expertise:  Due to the transdisciplinary nature of the projects and the focus on collaboration and expertise sharing, this FOA strongly encourages the use of the multi-PD/PI mechanism. This FOA is open to all collaborating teams with expertise in both physical sciences and cancer research. The Center Program Director/Principal Investigator (PD/PI) (contact PD/PI for applications with multiple PDs/PIs) must be a scientist with formal training and expertise in the physical sciences and/or engineering. Each applicant team must also include an additional PD/PI or other senior/key person with primary expertise in cancer research. Additional PD/PIs and key personnel should provide the appropriate breadth and balance of physical sciences and cancer research expertise.

PS-OC Organization:  Each PS-OC will consist of a transdisciplinary research team of investigators with complementary expertise organized around a scientific framework to address fundamental question(s) in cancer research. Each individual PS-OC will be governed by a Center Advisory Committee (CAC) with representatives from the physical sciences, cancer research, and NCI program staff.

Each Center will be nucleated around an organizing framework:

Each Center will consist of the following components:

PS-ON Organization:  The PS-ON will consist of all funded PS-OCs and PS-OPs and be governed by the PS-ON Steering Committee with representatives from funded Centers and Projects and NCI Project Scientists. Collaborative Network activities will allow Centers and Projects to cross-test ideas, integrate diverse data sets, and validate (or refute) theoretical, experimental, or clinical models.  

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
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs requested may not exceed $1.5M per year.

Award Project Period

Applicants may request project periods of up 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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

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.

Due to the transdisciplinary nature of the projects and the focus on collaboration and expertise sharing, this FOA strongly encourages the use of the multi-PD/PI mechanism. This FOA is open to all collaborating teams with expertise in both physical sciences and cancer research. The Center Program Director/Principal Investigator (PD/PI) (contact PD/PI for applications with multiple PDs/PIs) must be a scientist with formal training and expertise in the physical sciences and/or engineering. Formal training and expertise can be established through undergraduate or graduate degrees or through a body of work that demonstrates impact on the field. Each applicant team must also include an additional PD/PI or other senior/key person with primary expertise in cancer research and/or oncology. Primary expertise can be established through a body of work that demonstrates impact on the field.

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 any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

The letter of intent should be sent to:

Sean E. Hanlon, Ph.D.
Division of Cancer Biology (DCB)
National Cancer Institute (NCI)
Telephone: 240-276-5061
Email: sean.hanlon@nih.gov   

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Project

12

Core

12

Educ Outreach Unit

6


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions, with the following modifications:

Project Summary/Abstract: Describe overarching physical sciences-based organizing framework and overall summary/abstract for the entire PS-OC.

Project Narrative: The relevance of the overall PS-OC to public health should be stated.

Facilities and Other Resources: Provide a description of all resources for the overall PS-OC.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Specific Aims should be the overall vision and goals for the Center. These Aims should be overarching and at a high level and distinct from the aims of the individual components.   

Research Strategy: The Center Overview should present a concise overall vision and plan for the proposed PS-OC. The vision should focus on the plans for the funding period of the Center and may briefly highlight how the Center will lay the groundwork for longer term plans. This section should describe the physical sciences-based organizing framework for the Center that employs one or more of the thematic areas described above (or another scientifically justified physical sciences perspective of cancer) and the fundamental question(s) in cancer that will be addressed by the Center. Applications should demonstrate that a Center mechanism is essential to accomplishing the proposed studies. Additional items to be addressed include:

Letters of Support: An institution applying for a PS-OC should demonstrate a commitment to the proposed PS-OC's stability and success. Letter(s) of support from senior administration officials or other institutional officials from the PD(s)/PI(s)' institution(s) must be provided. The letter(s) should describe the level of institutional support for the Center including any leveraged funding or resources that may be provided by the institution(s). Additionally, the letter(s) should describe how and why the proposed PS-OC will be impactful.

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:

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.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Describe the overall goals and strategies for the Administrative Core.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

PS-OC PD(s)/PI(s) must each commit and maintain through the life of the award a minimum of 1.2 calendar months (CM) of effort.  The minimum of 1.2 CM time commitment may be an aggregate of efforts in different components.

Based on the complexity of PS-OCs, the Administrative Core Leader is strongly encouraged to propose and budget for a Center Administrator to manage day-to-day operations.

A minimum of $100,000 in direct costs per year must be allocated specifically for PS-OC Pilot Projects and a minimum of $100,000 in direct costs per year must be allocated specifically for Trans-Network projects.

The budget should include funds to support travel for Center and Network activities, including but not limited to supporting the participation of PD(s)/PI(s) and other Center members in the Annual PS-ON Investigators' Meeting and annual site visits.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims:  Succinctly describe the strategies and goals for managing the PS-OC and connecting the Center to the broader Physical Sciences-Oncology Network (PS-ON). 

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to: support transdisciplinary physical sciences in oncology research, training, and outreach; foster synergy and integration of the Center; and support planning and evaluation activities. The Administrative Unit will support and coordinate project administration within the individual PS-OC, and organize the Center Advisory Committee (CAC), and coordinate participation in the PS-ON Steering Committee. All applicants are expected to apply project management methods for planning, monitoring, and managing the workload over the award period and are expected to communicate this to NCI program staff upon request.

Applications must describe the administrative structure to support the proposed PS-OC, including but not limited, to:

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:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource 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  (Administrative Core)

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 (Administrative Core)

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

Research Projects

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Projects)

For each Research Project, complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide an abstract/summary for the proposed Research Project, including how it fits within the organizing framework of the Center.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

Budget (Research Projects)

Budget forms appropriate for the specific component will be included in the application package.

The Project Lead(s) must each commit and maintain through the life of the award a minimum of 0.6 CM of effort.  If there are multiple Project Leads, it is not necessary that each commit equal effort to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Research Projects)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: This section should include the specific aims of the Research Project and provide a rationale and description of how it fits into organizing framework of the Center.

Research Strategy: This section should describe the overall strategy for the Research Project and provide a concise discussion of how the Project is integrated within the Center. The Research Project should focus on innovative approaches that integrate physical sciences and cancer research perspectives to address fundamental question(s) in cancer research.

If the Research Project will utilize the Shared Resource Core(s), the application should describe how the Core(s) capabilities impact the proposed project.

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:

Resource Sharing Plans should only be included in the Overall Component. Individual components will adhere to the overarching Resource 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  (Research Projects)

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 (Research Projects)

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

Shared Resource Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Shared Resource Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Shared Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resource Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide an abstract/summary for the proposed Shared Resource Core, including which Research Projects will be supported by the Core.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Shared Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Shared Resource Core)

Budget (Shared Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

The Core Lead(s) must each commit and maintain through the life of the award a minimum of 0.6 CM of effort.  If there are multiple Core Leads, it is not necessary that each commit equal effort to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Shared Resource Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: This section should include the specific aims of the Shared Resource Core and describe which projects will be supported by the Core.

Research Strategy: The Shared Resource Cores may be physical or virtual infrastructures providing a biological or physical science resource that supports other Center components in their activities. Each Shared Resource Core is expected to support two or more Research Projects and the services and resources provided to other Center components should be clearly defined. Issues to be addressed include, but are not limited to: value of the Core services to the Center and Research Projects, integration between the Core and Projects, quality control, procedures for selecting Projects to use the Core and allocating resources, cost effectiveness, and increased efficiency. Training in complex techniques and methods should be described if they are functions of the proposed Core. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).

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:

Resource Sharing Plans should only be included in the Overall Component. Individual components will adhere to the overarching Resource 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  (Shared Resource Core)

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 (Shared Resource Core)

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

Education & Outreach Unit

When preparing your application in ASSIST, use Component Type ‘Educ Outreach Unit.’

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

SF424 (R&R) Cover (Education & Outreach Unit)

Complete only the following fields:

PHS 398 Cover Page Supplement (Education & Outreach Unit)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Education & Outreach Unit)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Describe the overall goals of the Education & Outreach Unit.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Education & Outreach Unit)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Education & Outreach Unit)

Budget (Education & Outreach Unit)

Budget forms appropriate for the specific component will be included in the application package.

A minimum of $100K direct costs per year must be allocated to the Education & Outreach Unit.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Education & Outreach Unit)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Succinctly describe the strategies and goals for managing of the Education & Training Unit.

Research Strategy: The Education & Outreach unit will serve to promote the education, training, and career development of researchers at all career stages and to disseminate advances and capabilities of physical sciences in oncology research to the broader cancer research and physical sciences communities. The proposed activities should relate to and integrate with the organizing framework of the Center. Potential activities include but are not limited to:

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:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource 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  (Education & Outreach Unit)

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 (Education & Outreach Unit)

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) using ASSIST or other electronic submission systems. 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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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, NIH. Applications that are incomplete will not be reviewed.

Pre-Application Information Webinar

An Applicant Information Webinar will be held on Wednesday, April 30, 2014, from 3 – 4:30 pm EDT, to provide information about the FOA to prospective applicants.  NCI staff will provide an overview of the FOA and answer questions.  The webinar is open to all prospective applicants.  Participation in the teleconference is not a prerequisite for applying, and is not required for a successful application.  Information about how to participate in the webinar will be posted at http://pson.cancer.gov.  Potential applicants are encouraged to signify their intent to participate and submit their questions or comments to nci.physics@mail.nih.gov prior to the meeting.  Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site.

Information Webinars will be held 1-2 months prior to subsequent receipt dates and information about dates, times, and how to participate will be posted at http://pson.cancer.gov.

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.

For this FOA, note the following:

Reviewers will provide an impact score for the entire PS-OC (Overall Impact - Overall) and individual components of the Center (Research Projects, Shared Resource Core(s), and Education & Outreach Unit). Reviewers will provide individual criterion scores for the entire PS-OC and for the Research Projects, but not for other components. They will also provide appropriately detailed written critiques for all components of the application.

The organizing framework and Research Projects make up the foundation of the PS-OC with additional components enhancing and integrating the overall research program. The overall impact score for the entire PS-OC may be higher or lower than the average of the individual components based on assessment of whether the whole is greater than the sum of its components.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific to this FOA:

How well does the organizing framework of the Center provide a physical sciences and/or engineering perspective of cancer that has the potential to address fundamental question(s) in cancer research? How well do the individual components coalesce to form a Center that is greater than the sum of its parts?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Specific to this FOA:

Does the PD/PI (contact PD/PI for applications with multiple PDs/PIs) have formal training and expertise in the physical sciences and/or engineering? Does the Center leadership team have the appropriated breadth and balance of physical sciences and/or engineering and cancer research and/or oncology expertise? Do the Center PD(s)/PI(s), Project Leads, and other key personnel have the necessary combined physical sciences and cancer research expertise? How well do the expertise of the physical scientists and cancer researchers complement each other? How well do the proposed interactions and collaborations between the Center PD(s)/PI(s), Project Leads, and other key personnel unite the components and advance the science of the Center? How well does the proposed Center support and nurture a team science environment that can lead to important advances in cancer research through physical sciences perspectives and approaches?

Innovation

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

Specific to this FOA:

How innovative is the physical sciences-based organizing framework of the Center? Does the Center propose to develop high-risk/high-reward Pilot and Trans-Network projects that advance the Center’s organizing framework? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

How well does the organizing framework of the Center integrate perspectives and approaches from the physical sciences and cancer research to address fundamental question(s) in cancer research?  

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?

Specific to this FOA:

How well does the Center environment promote collaborations and transdisciplinary research?  

Integration

How well does the application describe a truly integrated “Center” rather than a collection of unrelated research projects and support services? Will the whole Center be greater than the sum of its individual components? How well does the Center organization promote scientific and administrative integration and synergy and a cohesive research program? How well does the Administrative Core and the Center management plan provide for effective communication, interaction, and coordination among the investigators and components of the Center? Do the applicants state their willingness to collaborate and share models, software, and other resources within the Center and across the Network?

Scored Review Criteria - Research Projects

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 Center 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?

Specific to this FOA: How well does the Project address fundamental question(s) in cancer research from a physical sciences and/or engineering perspective? How well does the Project test and advance the physical sciences based organizing framework of the Center?

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?

Specific to this FOA: How well does the Project utilize the combined physical sciences and cancer research expertise to address important questions in cancer research? How does the Project benefit from the unique scientific expertise of the Center?

Innovation

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

Specific to this FOA:

How innovative is the Project's application of physical sciences and/or engineering based approaches and perspectives to cancer research?

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?

Specific to this FOA: How well does the Project integrate perspectives and approaches from the physical sciences and cancer research to address fundamental question(s) in cancer research?

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?

Specific to this FOA: How well does the Project environment promote collaborations and transdisciplinary research?

Integration

How well is the proposed Project integrated with other Research Projects and the overall Center? How well does the Project further the Center's organizing framework? How well does the project take advantage of the Center infrastructure to allow for alternative approaches or perspectives to be quickly employed? If the Project is supported by a Core, how well integrated are the Project and Core?

Review Criteria - Shared Resource Cores

Criterion scoring is not used for the Shared Resource Cores. Reviewers will consider the following criteria to determine an impact score:

Review Criteria - Education & Outreach Unit

Criterion scoring is not used for the Education & Outreach Unit. Reviewers will consider the following criteria to determine an impact score:

Additional Review Criteria   

As applicable for the Center 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 Center 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the Center.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations   

As applicable for the Center 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 National Cancer Institute 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:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . 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:

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.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

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 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 responsibility for:

A designated NCI Program Director acting as a Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Specifically, the NCI Project Scientists will:

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PS-ON Steering Committee, composed of the leadership of each Center and Project and NCI Project Scientists, will be responsible for Network coordination and governance. The Steering Committee will consist of:

(1) The PD/PI (contact PD/PI for Centers with multiple PDs/PIs) representing the physical sciences and one senior/key person representing cancer research, from each awarded PS-OC;

(2)  The PD/PI (contact PD/PI for Projects with multiple PDs/PIs) representing the physical sciences and one senior/key person representing cancer research, from each awarded PS-OP;

(3) NCI Project Scientist(s);

(4) Non-voting external scientific advisors.

Each PS-OC and PS-OP will have one vote and, based upon the actual number of awarded Centers and Projects, the number of NCI votes will be adjusted so that the ratio of NCI votes to Center and Project votes does not exceed 1:3.  Additional NIH/NCI Program Officials and Project Scientists and other government staff may participate in PS-ON Steering Committee meetings as non-voting members. The structure is designed to allow awarded investigators and NCI Project Scientists to work together to facilitate and develop collaborative Trans-Network pilot projects and other Network activities based on synergistic expertise and projects.

The PS-ON Steering Committee will elect one physical scientist and one cancer researcher to serve as co-chairs for a 6-month term (with a potential second term) starting at the first meeting of the Steering Committee following award. All PS-ON Steering Committee decisions and recommendations that require voting will be based on a majority vote. Centers and Projects will be required to accept and implement policies approved by the Steering Committee.

The PS-ON Steering Committee will:

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 PS-ON 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or 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. 

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)

Sean E. Hanlon, Ph.D.
Division of Cancer Biology (DCB)
National Cancer Institute (NCI)
Telephone: 240-276-5061
Email: sean.hanlon@nih.gov

Larry A. Nagahara, Ph.D.
Division of Cancer Biology (DCB)
National Cancer Institute (NCI)
Telephone:  240-276-7610
Email:  larry.nagahara@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Jennifer Meininger
National Cancer Institute (NCI)
Telephone: 240-276-6302
Email: meiningerjs@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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