It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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 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 PAR-15-021) and the PS-OC U54s (PAR-14-169). This PS-OP FOA provides opportunities for 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 goal of improving cancer prevention, detection, diagnosis, prognosis, and therapy.

Background

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 first phase of the PS-OC Program through 2015 generated several 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 continuation 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 program, which includes the U01 collaborative research Projects (PS-OP) and the U54 Centers (PS-OC).

Research Objectives

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 U01 research project.

Potential areas of investigation include but are not limited to those described below.

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 topics are not limited, the following represents two examples of research areas and 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 approaches can be augmented 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 mechanics 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, tissue mechanics) to better define mechanisms of progression and resistance and develop alternative therapeutic strategies?
• How can we better understand information flow in cancer within individual cells, among different cell populations, and at a patient scale and using approaches such as nonlinear feedback systems, game theory, control theory and/or machine learning/artificial intelligence?
• 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?

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

Organization of Individual PS-OPs and the PS-ON

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.

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

• Projects which do not involve a clear, well-integrated physical sciences perspective or approach to the cancer research question
• Projects focused on the development of nanotechnologies, microscopic or radiomic imaging modalities for cancer research should consider the FOA(s) offered by the NCI Innovative Molecular Analysis Technologies (IMAT) Program or the Cancer Imaging Program (CIP)
• Projects focused on emerging questions in cancer systems biology should consider the FOA(s) offered by the NCI Cancer Systems Biology Consortium (CSBC) Program
• Projects focused on the development of informatics technology should consider the FOA(s) offered by the NCI Informatics Technology for Cancer Research (ITCR) Program.

PS-ON Organization: The PS-ON will consist of all funded PS-OP U01 Research Projects and PS-OC U54 Research Centers and be governed by the 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. Trans-Network projects are not required to be described in the grant application.

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

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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 Zahir, Ph.D.
National Cancer Institute (NCI)
Division of Cancer Biology (DCB)
Telephone: 240-276-7610
Email: nas.zahir@nih.gov

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.

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., $15K for a requested budget of $250K 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 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.
• Sharing plans are expected to address the NIH Genomic Data Sharing Policy if applicable (i.e., if the proposed studies will generate large-scale human or non-human genomic data; see NOT-OD-14-124 for additional guidance).
• Data, software, and models from this FOA are expected to be shared in an easily accessible format 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 describe the types of data, software, and models that are expected to be generated and shared, including the resources required to facilitate data sharing that is 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 and/or other public access databases, consistent with achieving the goals of this program.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission 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, transdisciplinary Physical Sciences-Oncology Projects (PS-OPs).

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation

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.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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, engineering and cancer research expertise to address important questions in cancer research?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), 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 to address fundamental question(s) in cancer research?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 foster collaborations and transdisciplinary research?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 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.

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 individuals of all ages (including children and older adults) 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

Not Applicable.

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.

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.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 submitted to this FOA. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

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 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, 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 NCI funding the grant.
• 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 Project personnel 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 DHHS, 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 NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. 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. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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

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

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

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Nastaran Zahir, Ph.D.
National Cancer Institute (NCI)
Division of Cancer Biology (DCB)
Telephone: 240-276-7610
Email: nas.zahir@nih.gov

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

Mutema Nyankale
National Cancer Institute (NCI)

Office of Grants Administration (OGA)
Telephone: 240-276-5987
Email: mutema.nyankale@nih.gov

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 Part 75.