Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Planning for a National Center for Particle Beam Radiation Therapy Research (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of PAR-13-096

Related Notices

  • November 6, 2013 - See Notice NOT-CA-14-001. Notice of Change in Application Due Date.

Funding Opportunity Announcement (FOA) Number

PAR-13-371

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.395

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage and support planning efforts for establishing a Center for Particle Beam Radiation Therapy (PBRT) Research. The Center must be planned to operate as a research center adjunct to an independently created and funded, sustainable clinical facility for PBRT. Ultimately, the proposed Center is expected to perform clinically relevant research using proton and heavier ion beams (including but not necessarily limited to carbon beams). The goal of this FOA is to provide the awardees with funding to enable inclusion of necessary resources (expertise or facilities) to carry out basic, and translational, and clinical research complementary to a clinical PBRT facility. The necessary expertise and efforts would be provided by a multidisciplinary team of basic, translational, and clinical researchers, including physicists, engineers, biologists, and physicians, while the research facilities may include, by way of example, cell culture laboratories, vivarium, and clinical anesthesia units for pediatric patients. Applicants responding to this FOA must propose at least one pilot project that will enable a PBRT research agenda in particle beam delivery systems, dosimetry, radiation biology, or translational pre-clinical studies. It is expected that this effort will lead to a national research resource capable of successfully competing for and securing the funding required to operate a specialized research center for clinical PBRT. This FOA is designed to support solely the planning for a Research Center at a separately funded PBRT facility, and not the PBRT facility itself.  

Key Dates
Posted Date

October 17, 2013

Open Date (Earliest Submission Date)

December 21, 2013 

Letter of Intent Due Date(s)

December 21, 2013

Application Due Date(s)

(New Date February 24, 2014 per NOT-CA-14-001), Originally January 21, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

(New Date June/July 2014 per NOT-CA-14-001), Originally June 2014  

Advisory Council Review

October 2014  

Earliest Start Date

December 2014

Expiration Date

(Extended to February 25, 2014 per NOT-CA-14-001), Originally January 22, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage and support planning efforts for establishing a center for Particle Beam Radiation Therapy (PBRT) Research. The Center must be planned to operate as a research center adjunct to an independently created and funded, sustainable clinical facility for PBRT. This FOA is designed to support solely the planning for a Research Center at such a separately funded PBRT facility, and not the PBRT facility itself. Ultimately, the proposed Center is expected to perform clinically relevant research using proton and heavier ion beams (including but not necessarily limited to carbon beams). The goal of this FOA is to provide the awardees with funding to enable inclusion of necessary resources (expertise or facilities) to carry out basic, translational, and clinical research complementary to a clinical PBRT facility. The necessary expertise and efforts would be provided by a multidisciplinary team of basic, translational, and clinical researchers, including physicists, engineers, biologists, and physicians, while the research facilities may include, by way of example, cell culture laboratories, vivarium, and clinical anesthesia units for pediatric patients. Applicants responding to this FOA must propose at least one pilot project that will enable a PBRT research agenda in particle beam delivery systems, dosimetry, radiation biology, or translational pre-clinical studies. It is expected that this effort will lead to a national research resource capable of successfully competing for and securing the funding required to operate a specialized research center for clinical PBRT.  

Background

Limitations of conventional (x-ray) radiation therapy

Radiation therapy is a treatment modality for nearly two-thirds of all cancer patients. In a number of common cancers, however, a majority of the patients suffer local recurrence after radiation therapy and often die as a result (examples include patients with glioblastoma and locally advanced cancers of the head and neck, lungs, esophagus, and pancreas). In addition, a considerable proportion of the radiation-treated patients suffer adverse effects during and after radiation therapy.

Although existing technology, such as intensity modulated radiation therapy (IMRT) with photon (X-ray) beams, allows delivery of a well-defined, conformal dose to the target (tumor) volume, it can be achieved only by directing the beams from multiple angles. Consequently, normal tissues are exposed to low doses of radiation as the individual X-ray beams enter and leave the body, increasing the risk for long-term side effects including secondary cancers.

Potential advantages of particle beam radiation therapy

Particle beam radiation therapy offers advantageous physical-dose distributions (protons and heavier-ion beams) and biological potential (heavier-ion beams) as compared to photon radiotherapy. The physical dose distribution advantage of charged-particle beams results from the fact that they stop at a depth defined by their energy and, thereby, spare normal tissues beyond the target from unwanted radiation. A considerable body of experimental and clinical, treatment-based evidence indicates that in certain settings particle beams might be equally, or more, effective in treating cancer as the most sophisticated photon-based therapies while significantly reducing the volume of normal tissue irradiated. However, there is still a pressing need for more extensive clinical trials to determine appropriate and optimal use of particle beam therapy.

Because of the physical stopping of protons and heavier-ion particles at well defined depth in the tissue, particle beam treatments may target tumors from a single direction or just a few directions which can be chosen to avoid the most sensitive tissues/organs. Therefore, adults with lung cancer and cancers of the head and neck, brain, base of skull, eye, pancreas, and prostate might benefit from the advantages of particle beam therapy. The benefits may even be greater for children as the normal tissues are spared from radiation and, thereby, the risk for the development of radiation-associated cancers and functional abnormalities is minimized. Radiobiological experiments with particle beams show that particle beams (most commonly using carbon ions) provide a unique advantage of not only well defined range in the tissue but also high biological effectiveness, resulting in more damage to the irradiated tumor tissue per unit of radiation dose delivered to the target volume as compared to photons and protons. In addition, hypoxic tumor cells -­- the most radiation resistant and aggressive tumor cells -- are killed more efficiently with particle beams than with photons.

Need for further research and clinical trials

Although significant progress has been made in the use of particle beams for cancer treatment, an extensive research and development program is needed to maximize the healthcare benefits from these therapies. Since a typical facility may cost well over $100 million to design and construct, and millions each year in operating costs, there is a need for studies comparing the effectiveness of photon, proton and heavier-ion therapy in a number of situations where particle therapy is expected to have a clear advantage (go to: http://www.ahrq.gov/news/press/pr2009/probeampr.htm). Basic biological studies to characterize such specific cases as, for example, hypoxic tumors must be conducted. Clinical physics research is needed to further streamline treatment and develop improved techniques for treatment planning and delivery. Additionally, accelerator research and development aimed at improving the technology for producing and delivering particle beams are expected to reduce the complexity and cost of the equipment as highlighted in a recent report by the Department of Energy: "Accelerators for America's Future" (go to: http://www.acceleratorsamerica.org/report/index.html).

Currently operating carbon-ion therapy centers worldwide include two in Japan and one in Germany, with others in various stages of development. Although, as of September 2013, there are no announced plans of such a facility in the U.S., there is a strong interest in the U.S. radiation oncology community to investigate possible application of particle beams (especially carbon) for cancer treatment, and to compare therapeutic efficacy of different types of charged particles to those of photons and protons. Thus, there is need for a research facility that would allow U.S. scientists to participate in research on oncological applications of a spectrum of particle beams, including carbon-ion beams.

Specific Areas of Research Interest

The application should be focused on specific goals relevant to establishing research capacity into the design, construction, and operation of a planned PBRT facility. For example, the proposed goals may include but are not limited to the following activities:

Specific Requirements

Commitments to research activities in the planned PBRT facility. Applicants responding to this FOA should have advanced plans and documented commitments to construct a viable and independently supported PBRT facility. It is expected that these advanced plans and commitments will reflect such aspects as:

Ability to plan and develop appropriate basic, translational, and clinical research capabilities. Applicants responding to this FOA should assemble teams with appropriate expertise and should be able to propose specific plans and steps to incorporate research activities as an integral part of the planned PBRT facility.

Pilot Research Project(s). These pilot project(s) are expected to have a clear potential to transition the approaches, results, collaborations established, etc., to the research activities at the planned PBRT facility.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Resubmission ( only applications originally submitted to PAR-13-096)

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

Funds Available and Anticipated Number of Awards

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

The NCI anticipates funding up to two awards.

Award Budget

Applications may request a maximum annual budget of $500,000 total costs. However, application budgets need to reflect actual needs of the proposed project.

Award Project Period

The maximum project period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

James A. Deye, Ph.D.
Clinical Radiation Oncology Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)
9609 Medical Center Drive
RM 3W234 MSC 9727
Bethesda, MD 20892-9727
Telephone: 240-276-5690 (main)
Fax: 240-276-5827
Email: deyej@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Research Core

6

Pilot Project

12


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

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: Applicants must provide, as one PDF file (Supplementary Documentation, maximum 50 pages), additional materials describing in detail the facilities and infrastructure proposed for the planned PBRT, including:

Institutional Commitment

Access to Required Specialized Resources

Facilities for Basic, Translational, and Clinical Research

Research Infrastructure

For applications involving a Consortium

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmissions, an Introduction to Application is required in the Overall component

Specific Aims: Outline the overall goals of this application relevant to establishing research capacity into the design, construction, and operation of a planned PBRT facility.

Research Strategy: Describe an overall organization and management plan for the proposed PBRT center:

Describe how specific goals of this project are relevant for building research capacity into the operation of the planned PBRT facility.

The applicants are also expected to summarize their current and past scientific collaboration (as documented by joint publications and/or grants) as well as plans for the future collaborations. In the narrative describe how these efforts are expected to create a critical mass of relevant expertise. Outline also plans for obtaining funding from multiple sources for particle beam research and development in the future.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

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

Budget (Administrative Core)

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

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

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

PHS 398 Research Plan          (Administrative Core)

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

Specific Aims: Provide a description of the main tasks for the Administrative Core.

Research Strategy: Describe specific administrative tasks relevant for building research capacity into the operation of the planned PBRT facility. For example, the proposed activities may include but are not limited to the following activities:

A clear plan for the transition of the proposed project activities in this application to the research activities of the planned PBRT must be included. This plan should also describe how the applicant(s) intend(s) to make the transition from support of this FOA to the future competitive grant support obtained through applications submitted to relevant NIH Institutes and Centers or other appropriate Federal or non-Federal agencies or organizations.

For consortia, describe plans for coordination and cooperation among research project investigators and mechanisms to ensure smooth administration of this project across the institutions.

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report  (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Research Core

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

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

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

Project Narrative:  Do not complete.

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

List all performance sites that apply to the specific component.

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

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

Budget (Research Core)

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

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

PHS 398 Research Plan (Research Core)

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

Specific Aims: Provide a description of the overall PBRT Research Core.

Research Strategy: The applicant should indicate how the core will serve the scientific needs of the individual research project(s), and how the core will impact the development and sustainability of the research activities at the planned PBRT. The core description should indicate the qualifications of personnel selected to manage the facility and/or plans to recruit personnel to operate the core; however, specific names are not required.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed research core should be included.

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 modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Core)

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

Pilot Project

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

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

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project)

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

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

Project Narrative: Provide a short description of the proposed research goals and their relevance to the planned PBRT.

Project /Performance Site Location(s) (Pilot Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Pilot Project)

Budget (Pilot Project)

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

Individual research projects should have a detailed budget for the entire proposed project period (2 years maximum).

PHS 398 Research Plan  (Pilot Project)

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

Specific Aims: Outline the hypothesis (or central problem) of the project and explain how it fits into the overall plans for incorporating research activities into a PBRT facility.

Research Strategy:  Research Strategy is expected to focus on specific project goals relevant to building research capacity into the operation of the planned PBRT facility. For example, the proposed project may include but are not limited to the following activities:

Describe the research strategy of the project in a similar format and level of detail as required for an investigator-initiated single-project grant application.  The project should have the following sub-sections: Background and Significance, Rationale, and Approach.

Background and Significance.  Describe the central problem/hypothesis to address and describe how the proposed research will contribute to meeting the goals and objectives of the entire application.

Rationale.  Include any data and rationale supporting the proposed hypothesis and/or focal point of the research project.  Original research preliminary data are not required but encouraged if available. Regardless of the availability of preliminary data, the concepts for the proposed projects must be well developed and rigorous.

Approach.  Explain the rationale for selecting the methods to accomplish the Specific Aims of the project.  Describe the research design, conceptual procedures, and analyses to be used.  Describe any new methodology and its advantage over existing methodologies.  Describe any novel concepts, approaches, tools, or technologies for the proposed studies.  Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.  Provide a tentative timetable for the project.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed research project should be included.

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.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Project)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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?   

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 experienced are the applicants in organizing/conducting, directing research efforts of the size and scope suitable for a national research resource?

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?   

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: How relevant are the pilot project(s) and other proposed research activities to establishing a biomedical research capacity within a multi-particle capable radiotherapy facility? Will the proposed research activities contribute to improvements in the particle therapy facility which will enhance its utility as a national particle beam therapy research resource? Are the proposed research activities well matched to the available facilities and collaborations? Will the proposed research activities promote collaboration and exchange of information and ideas between pre-clinical and clinical researchers? Is the research integrated across partner institutions as evinced by programmatic structure and objectives, joint publications and grants, a history of research integration or the provisions of formalized legal agreements and other trans-disciplinary, cross-institutional activities? Are the nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators appropriate and will they contribute to the establishment of the research center in the future? Are there adequate mechanisms to ensure smooth administration of the proposed research activities across the institutions?

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?   

Additional Review Criteria

As applicable for the overall PBRT facility) 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.

FOA-Specific Review Criteria

The specific character of this planning FOA requires the following additional considerations regarding the facilities and infrastructure of the planned PBRT described in the Overall Component.

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 clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. 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

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

James A. Deye, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: deyej@nih.gov

Jacek Capala, Ph.D., D.Sc.
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: capalaj@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Ms. Renee Carruthers
National Cancer Institute (NCI)
Telephone: 301-631-3018
Email: renee.carruthers@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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