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.

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

The purpose of this funding opportunity announcement (FOA) is to invite applications for Physical Science-Oncology Projects (PS-OP). The goal of the PS-OPs is to promote a physical sciences perspective of cancer and foster the convergence of physical science and cancer research by forming small transdisciplinary teams of physical scientists (e.g., engineers, physicists, mathematicians, chemists, computer scientists) and cancer researchers (e.g., cancer biologists, oncologists, pathologists) working very closely together to advance our understanding of cancer biology and oncology. The transdisciplinary nature of the Projects will require the formation of small collaborative research teams around a physical sciences-based framework to address fundamental questions in cancer research. The PS-OPs will develop and test physical sciences-based experimental and theoretical concepts that complement and advance our current understanding of cancer. The PS-OPs, individually and along with other PS-OPs and the Physical Sciences-Oncology Centers (PS-OC), will form the Physical Sciences-Oncology Network (PS-ON). The Physical Sciences-Oncology initiative is expected to further develop emerging fields of study in cancer that are based on physical sciences principles and approaches.

The Network will include both the PS-OP U01s (this FOA) and the PS-OC U54s (PAR-14-169). This PS-OP FOA provides opportunities for investigators or small teams with the necessary expertise to address specific, focused cancer research questions from a physical science perspective or approach. Investigators from both the PS-OPs and PS-OCs will be expected to collaborate and share data and expertise across the Network and participate in collaborative Network activities and annual meetings. The aim of the PS-ON is to integrate physical sciences perspectives into cancer research to complement and expand our current understanding of cancer biology across many biological length-scales and time-scales, with the ultimate goal of improving cancer prevention, detection, diagnosis, prognosis, and therapy.

In 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 (http://pson.cancer.gov). Each Center conducted transdisciplinary research integrating the perspectives of physicists, mathematicians, chemists, engineers, computer scientists, cancer biologists, and oncologists to examine cancer biology using approaches and theories from the physical sciences. The original PS-OC Program generated a number of discoveries and made steady progress towards its scientific and programmatic goals. Highlights of research advances made by the PS-OCs include: 1) understanding mechanisms behind the generation of mutations in cancer genomes based on 3-D architecture and polymer physics, 2) optimizing dosing strategies for lung and brain cancer treatment using computational physics and evolutionary theory, and 3) progress in understanding the role of mechanics in tumor progression and metastasis using physical parameters.

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 assess the progress of the PS-OC Program and to identify areas that merited continued or required 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 as described in the workshop reports helped shape the scientific and structural elements of the ongoing PS-ON, which will include the U01 collaborative research Projects (PS-OP) and the U54 Centers (PS-OC).

The aim of the PS-ON is to integrate physical sciences and cancer research perspectives and approaches to address complex and challenging questions in cancer research. This FOA for PS-OPs invites a broad range of research that addresses important cancer questions from a physical sciences perspective. Applicants may focus on one of the suggested 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 into a discrete, specified, circumscribed collaborative research project.

Potential areas of investigation as indicated for each NIH Institute participating in this funding opportunity includes but is not limited to those described below.

NCI:

Understanding and applying physical science perspectives and approaches to cancer biology and oncology can cover a variety of topics and areas of research. While the research topic is not limited, the following represents two examples of research areas and the type of questions that could be framed within an application.

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 biological 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 understanding the biology of cancer. Potential questions to be addressed include, but are not limited to:

• What are the physical origins of genomic instability and mutagenesis in relation to the energetics of protein-DNA interfaces and packaging, dynamic epigenetic states, and higher-order genome organization? How do these physical parameters affect initiation, progression, or response to treatments and can these physical features be exploited for potential diagnosis or prognosis?

• How do physical properties and mechanics of tumors, disseminating cells, and sites of colonization and metastasis contribute to metastasis and dormancy? How do these factors affect cancer progression and evolution of therapeutic resistance?

• How can physical properties such as forces serve as biomarkers or signatures that can be used to evaluate a metabolic state or be an (early) indicator of the disease?

• What roles do the physical properties of tumor systems play in the bidirectional communication between tumor and host? How do changes in these properties or their gradients contribute to metastatic processes or dormancy?

Spatio-Temporal Organization and Information Transfer in Cancer: Appropriate spatial and temporal organization of structures across many biological and physical 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 evolution 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 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:

• How is the spatial organization of the nucleus and other organelles modulated by extrinsic physical factors? How do changes in organelle organization affect initiation and progression of cancer? How can these alterations in spatial organization be exploited for cancer detection or prognosis?

• Using physical science approaches such as those mentioned above, how do the dynamics of molecular and cell crowding, phenotypic variation, cell population diversity, and extracellular matrix and vascular architecture in tumors affect cancer initiation, progression, metastasis, and response to treatment?

• How can the evolutionary dynamics of therapeutic resistance be examined in the context of dynamic spatio-temporal environments (e.g., oxygen, drugs, nutrients) to better define mechanisms of progression and resistance and develop alternative therapeutic strategies?

• How can nonlinear feedback systems, game theory, and/or control theory approaches be applied to cancer research to understand information flow in cancer at a patient scale, among different cell populations, and within individual cells?

• How do we study, quantify, integrate, and model the complexity of tumor development across multiple length- and time-scales? That is, how do changes at the molecular and cellular level affect the overall development, structure, and organization of a tumor and vice versa?

NIBIB:

Interests for NIBIB lie in the development of innovative technologies and analytical and computational tools to explore the process of tumor initiation and progression. Some examples include, but are not limited to the development of:

• Force probes to measure mechanical forces in cancer;

• Micro-fluidic devices to model the 3D tumor microenvironment;

• Novel materials and matrices to study the metastatic process;

• Formulation of predictive, multiscale mathematical models of metastasis and angiogenesis;

• New imaging techniques to characterize physical changes in cells in transition from non-cancerous to metastatic.

NICHD:

NICHD’s focus in this FOA is to promote studies addressing developmental mechanisms relevant to cancer cell biology. It is also important to note that NICHD will only support studies conducted in vivo, as emphasized below:

• The research activities must be confined to embryonic development, such as the physical mechanisms contributing to embryonic morphogenesis, tissue patterning, and spatio-temporal organization, in the context of cancer biology.

• In vivo experimental systems to be used are confined to multicellular vertebrate or invertebrate animal models.

Theoretical model- or hypotheses-driven studies conducted in tissue explants and/or cell culture-based in vitro experimental systems should be extended to include in vivo systems.

All of the above examples of possible research directions are not meant to be comprehensive.

PS-OP 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 option with a small team of combined expertise from the physical sciences and cancer research. When applicable, additional PD/PIs, key personnel, and collaborators should consist of a transdisciplinary research team with complementary abilities organized around a scientific framework to address fundamental question(s) in cancer research. It is recognized that there may be instances where a single PD/PI will already have the combined expertise to bring a physical science perspective to study an important problem in cancer research and may not need to use the multi-PD/PI option.

PS-OP Requirements: PS-OP applications should propose a single, cohesive project. Applications proposing multiple projects are not appropriate for this FOA. Applicants interested in proposing more than one project may do so by submitting multiple applications or considering if the scope of the proposed research falls under the companion U54 PS-OC FOA (Centers).

In addition, the following types of projects are not considered to be of high programmatic priority:

• Projects which do not involve a clear, well-integrated physical sciences perspective or approach to the cancer

• Projects focused on the development of nanotechnologies for cancer research should consider the FOAs offered by the NCI Alliance for Nanotechnology in Cancer Program (RFA-CA-14-013; PAR-14-285)

• Projects focused on the development of informatics technology should consider the FOAs offered by the Informatics Technology for Cancer Research (ITCR) Program (PAR-12-286; PAR-12-288; PAR-12-289; PAR-13-294; PAR-13-330).

PS-ON Organization: The PS-ON will consist of all funded PS-OPs and PS-OCs (invited through PAR-14-169) and be governed by a PS-ON Steering Committee. Collaborative Network activities, such as Trans-Network Projects, will allow PS-OPs and PS-OCs to cross-test ideas, integrate diverse data sets, and validate (or refute) theoretical, experimental, or translational models. Trans-Network Projects are small research projects aimed at a question in cancer-relevant biology from a physical sciences perspective that could be addressed by leveraging the expertise and investigators from multiple PS-OPs and/or PS-OCs. Topics and formats for Trans-Network Projects will be defined by the PS-ON Steering Committee. Investigators may propose a new or revised Trans-Network Project one or more times per year, as determined by the PS-ON Steering Committee and NIH Staff.

NCI will hold a pre-application informational webinar for this FOA. Date, time, and other details will be posted at http://pson.cancer.gov.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

• Private Institutions of Higher Education

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

• Hispanic-serving Institutions

• Historically Black Colleges and Universities (HBCUs)

• Tribally Controlled Colleges and Universities (TCCUs)

• Alaska Native and Native Hawaiian Serving Institutions

• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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

For-Profit Organizations

• Small Businesses

• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments

• County Governments

• City or Township Governments

• Special District Governments

• Indian/Native American Tribal Governments (Federally Recognized)

• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts

• Public Housing Authorities/Indian Housing Authorities

• Native American Tribal Organizations (other than Federally recognized tribal governments)

• Faith-based or Community-based Organizations

• Regional Organizations

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

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 Physical Sciences-Oncology Projects and the focus on collaboration and expertise sharing, this FOA strongly encourages the use of the multi-PD/PI option. This FOA is open to all collaborating teams with formal training and expertise in both physical sciences and cancer research. Formal training and expertise can be established through undergraduate or graduate degrees or through a body of work that demonstrates contribution to the field. It is recognized that there may be instances where a single PD/PI will already have the combined expertise to bring a physical science perspective to study an important problem in cancer research and may not need to use the multi-PD/PI option.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the 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.

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.

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Nastaran Z. Kuhn, Ph.D.
Division of Cancer Biology (DCB)
National Cancer Institute (NCI)
Telephone: 240-276-6333
Email: [email protected]

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

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.

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed in addition to the following instructions:

Trans-Network Projects:

• A minimum of 6% of the direct costs per year must be allocated in the proposed budget specifically for Trans-Network projects for leveraging the expertise of multiple PS-OPs and/or PS-OCs to test or validate new ideas (e.g., $30K for a requested budget of $500K direct costs).

Optional PS-OP Pilot Projects:

• It is optional to include up to 5% of the direct costs per year in the proposed budget specifically for PS-OP Pilot Projects (e.g., $25K for a requested budget of $500K direct costs).

Travel:

• Appropriate travel funds must be included in the proposed budget to support travel for at least one PS-OP PD/PI to the Annual PS-ON Investigators Meeting and/or a Steering Committee Meeting.

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

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

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

Research Strategy: PS-OP applicants should clearly describe what cancer research problem they plan to investigate and how the proposed physical sciences perspective or approach could bring novel insight to cancer biology and oncology.

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.

• Data, software, and models from this FOA are expected to be shared in an easily accessible format so as to increase the value of the significant public investment. Program staff may negotiate modifications to these plans prior to funding

• The resource sharing plan should briefly describe the types of data, software, and models that are expected to be generated and shared, consistent with achieving the goals of this program.

• The resource sharing plan should address sharing of data both within a Center and across the Network, consistent with achieving the goals of this program.

• The resource-sharing plan should address sharing of data through the PS-ON Data Coordinating Center, NCIP Hub for Physical Sciences in Oncology, and/or other public access databases, consistent with achieving the goals of this program.

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.

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

This initiative is not subject to intergovernmental review.

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.

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, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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 particular announcement, note the following:

The overarching goal of this FOA is to encourage convergence of physical sciences and/or engineering perspectives and approaches in cancer research by the proposal of collaborative Physical Sciences-Oncology Projects (PS-OPs).

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).

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?

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 do the aims test and advance the physical sciences based approaches of the Project? If the aims of the application are achieved, how will scientific knowledge in cancer biology be advanced?

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 represented by the PD/PI (and/or key personnel)?

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 novel 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?

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

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 project.

Renewals

Not Applicable

Revisions

Not Applicable

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

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.

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 . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.

• Availability of funds.

• Relevance of the proposed project to program priorities.

• Compliance with resource sharing policies, as appropriate.

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.

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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:

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI, NIBIB, and/or NICHD for the performance and proper conduct of the research supported by the PS-OP U01 award in accordance with these terms and conditions of the award.

Specific PD(s)/PI(s) responsibilities and rights will be to:

• Oversee the project as a whole, including defining the research objectives, conducting specific studies, analysis and interpretation of research data, preparation of publications, and disseminating approaches, methods, models, software, and tools broadly.

• Indicate appropriate PS-OP grant number on all related scientific research publications and acknowledge the appropriate NIH Institute(s) funding the grant.

• Administer pilot project funding, if applicable, as deemed necessary where scientifically meritorious work is proposed that fits within the overall scope of the PS-OP U01.

• Affiliate with the Physical Sciences-Oncology Network (PS-ON).

• Work with the NIH Project Scientist on the coordination of Network activities and the scientific integration of individual projects with the PS-ON. These actions may involve (but will not be limited to) the participation in appropriate coordinating meetings and/or working groups, and/or teleconferences as needed, attending the Annual PS-ON Investigators Meeting, participating in other Network meetings and workshops, participating in collaborative activities, and promoting Trans-Network collaborations.

• Collaborate with members of the PS-ON and external collaborators to advance and cross-test emerging physical sciences-based experimental and theoretical concepts and hypotheses.

• Serve on the PS-ON Steering Committee. The PS-OP U01 PD/PI (contact PD/PI for applications with multiple PDs/PIs) and one key Center person are required to serve as members of the Steering Committee and will collectively have one vote. The two members should collectively represent both the physical sciences and cancer research components of the U01.

• Respect the governance of the Network and all Network policies agreed upon by the PS-ON Steering Committee and approved by NIH Program Staff.

• Work with PS-ON colleagues (e.g., on a sub-committee or working group) to facilitate the scientific integration of PS-OPs with the respective PS-ON efforts and to maximize mutual scientific benefits.

• Ensure that data are deposited in a timely manner in the PS-ON Data Coordinating Center (PS-ON DCC) or other appropriate public databases, so that models, software, and other tools and resources developed as part of this project are made publicly available according to Network policies, and that results of the project are published in a timely manner.

• Organize scientific working groups to facilitate collaborative projects and cross-testing of experimental and theoretical concepts.

• Participate in the establishment of collaborative Network projects.

• In addition to providing standard annual progress reports (see Section VI.3. Reporting), each U01 awardee will be responsible for providing other relevant information (e.g., highlights of most recent publications) to the NIH Project Scientist, and coordinate and cooperate with NIH Program Staff and other members of the PS-ON program with whom they are collaborating.

• 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 NIH Program Director(s) acting as a Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Specifically, the NIH Project Scientists will:

• Provide substantial NIH scientific programmatic involvement, including serving as subject matter experts, providing scientific advice as needed.

• Serve as voting members of the PS-ON Steering Committee. The ratio of NIH Project Scientist votes to Center and Project votes will be adjusted to ensure the ratio does not exceed 1:3.

• Serve on PS-ON Steering Committee sub-committees or Network working groups and assist the Steering Committee in developing operating guidelines and consistent policies for dealing with situations that require coordinated action.

• Work with the PS-ON Steering Committee to develop policies and procedures for the solicitation and review of collaborative Trans-Network pilot projects.

• Serve as liaison across the Network.

• Facilitate coordination and collaboration among investigators within Projects and across the Network.

• Facilitate PS-OP U01 investigators' interaction with other NCI and NIH programs to effectively leverage existing NIH resources and infrastructures.

• Promote the dissemination of physical sciences in oncology training opportunities to the broader research community.

• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met. Specifically, the NIH Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures.

• Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

Additionally, an NIH Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist.

Areas of Joint Responsibility include:

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

The Steering Committee will consist of:

(1) The PD/PI (contact PD/PI for Projects with multiple PDs/PIs) and one key Project person who collectively represent both the physical sciences and cancer research components of the PS-OP U01;

(2) 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 U54;

(3) NCI/NIH Project Scientist(s);

(4) Non-voting external scientific advisors to the PS-OCs.

Each PS-OP and PS-OC will have one vote and, based upon the actual number of awarded Projects and Centers, the number of NCI/NIH votes will be adjusted so that the ratio of NCI/NIH votes to Project and Center votes does not exceed 1:3. Additional NCI/NIH 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/NIH 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 biologist or physician scientist to serve as co-chairs for at least 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. Projects and Centers will be required to accept and implement policies approved by the Steering Committee.

The PS-ON Steering Committee will:

• Identify scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and develop recommendations to NCI/NIH Program Officials and Project Scientists for addressing such issues.

• Review progress of the PS-ON toward meeting the overall Network goals.

• Develop policies and procedures for the solicitation and review of collaborative Trans-Network pilot projects.

• Discuss and recommend the development, review, and selection of Trans-Network projects.

• Coordinate the dissemination of the progress and promise of the Network to the broader cancer research and physical sciences communities.

• Coordinate Network publications.

• Review the potential of Shared Resource Core(s) at individual Centers to serve the needs of other Centers or Projects.

• Ensure that the Network leverages existing NCI and NIH resources and programs.

• Establish, as necessary, subcommittees to ensure progress of the individual Projects, Centers, and the Network.

• Schedule and organize an Annual PS-ON Investigators Meeting at which Network investigators will present their scientific progress, develop collaborations, and participate in working group discussions.

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 including one designee of the PS-ON Steering Committee chosen without NCI staff voting, one NCI 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.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Nastaran Z. Kuhn, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6333
Email: [email protected]

Larry A. Nagahara, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7610
Email: [email protected]

Rosemarie D. Hunziker, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]

Mahua Mukhopadhyay, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6886
Email: [email protected]

NCI Referral Officer
National Cancer Institute
Telephone: 240-276-6390
Email: [email protected]

Jennifer Meininger
National Cancer Institute (NCI)
Telephone: 240-276-6302
Email: [email protected]

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8521
Email: [email protected]

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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.

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.