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.

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

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.

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 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.

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:

• Development of design specifications for experimental beam delivery systems to provide a range of particle beams from protons to carbon or heavier ions;
• Development or implementation of radiation biology experimental research capabilities;
• Architectural designs and documentation to include research facilities and infrastructure;
• Establishment of infrastructure and personnel necessary to support research activities (including training as necessary); and
• Support of activities facilitating establishment of consortia necessary to create and implement a robust research agenda for a planned facility.

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:

• Funding and resources for the construction of PBRT facility;
• Appropriate business plans, consortia arrangements; and
• Commitment to future research activities aiming at providing major improvements in the particle therapy, including randomized clinical trials to test the efficacy of proton and heavier-ion therapies.

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.

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.

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) 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.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account 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.

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.

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.

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants 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.

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.

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:

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: [email protected]

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.

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: Required
• Administrative Core: Required
• Research Core: Optional
• Pilot Project: Required; maximum of 3

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

• Documented accomplishments of the applying institution(s) in research projects of the size and scope of a national research resource. Such accomplishments may include participation in leadership and/or participation in randomized multi-center clinical radiation therapy trials.
• Planned support for the development of a PBRT research multidisciplinary center.
• Plans necessary to obtain competitive grant support for the operation of planned PBRT research facility.
• Provision indicating that the PBRT research center status within the organizational structure of the institution(s) will be commensurate with its scope as a national research resource.

Access to Required Specialized Resources

• Assurance of timely construction of the clinical particle beam therapy facility.
• Applicants access to adequate funding and referral patterns.
• Localization in close proximity to a major oncology center to secure access to clinical inpatient and outpatient facilities for the conduct of clinical trials, as well as faculty and staff critical to clinical research.

Facilities for Basic, Translational, and Clinical Research

• Plans including facilities necessary to carry out a broad range of particle therapy-related research, including but not limited to, particle beam delivery systems and dosimetry, radiation biology, translational pre-clinical studies, and clinical trials such as:
  • relationships to particle beam accelerator development and engineering capabilities;
  • medical physics research facilities to investigate particle beam treatment planning and delivery systems;
  • particle beam line(s) dedicated to basic and translational radiation biology experiments
  • cell culture facilities and vivarium;
  • facilities for clinical research, e.g., clinical anesthesia unit for pediatric patients;
  • capacity to provide a spectrum of particle beams from protons to, at least, carbon ions.

Research Infrastructure

• Planned research infrastructure adequate to the research plans and the mission of a national center for PBRT.
• Roadmap to become an integral part of a major biomedical research institution, to foster scientific interactions and joint multidisciplinary initiatives.
• External and internal advisory bodies for strategic planning, decision-making, and priority setting. Describe the profiles of expertise desirable for the advisory bodies. However, to facilitate the review process, do not provide any names in the application and refrain from contacting potential candidates.
• Research activities and structure of the planned center facilitating:
  • major improvements in and understanding of PBRT;
  • effective trans-disciplinary and translational collaborations among the members of pre-clinical and clinical teams of the center;
  • participation of collaborators from other institutions;

For applications involving a Consortium

• Confirmation (or record) of the commitment of the parties to work in concert with one another around large, long-term goals.
• Research integration across partner institutions as evinced by programmatic structure and objectives, joint publications and grants, formalized legal agreements between the partners, and other trans-disciplinary, cross-institutional activities.

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:

• Availability of funding necessary to build a PBRT facility;
• The proposed time frame for completion of the facility along with elucidation of key milestones;
• Business model proposed that will support sustainable operations without compromising the research and development efforts, including basic research and clinical trials;
• Capacity to provide at least proton and carbon-ion particle beams;
• Access to specialized resources needed for translational research, including patient referral patterns and proximity to adequate hospital(s) and medical care;
• Adequate organizational capabilities;
• Leadership of the research activities; and
• Commitment to future research activities aiming at providing major improvements in the particle therapy, including randomized clinical trials to test the efficacy of proton and heavier-ion therapies.

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.

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:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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:

• Establishment of infrastructure, collaborations, and consortia necessary to create and implement a robust research agenda for a planned facility.
• Secure relevant expertise (including hiring and training as necessary); and
• Organization of workshops on relevant subjects.

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.

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:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

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)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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.

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:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

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)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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:

• design of experimental beam delivery systems to provide a range of particle beams from protons to carbon or heavier ions;
• development of medical physics-specific aspects (e.g. dosimetry, patient positioning and monitoring) of PBRT
• radiation biology, and translational pre-clinical studies, and
• optimization of research infrastructure to be included into a planned PBRT facility.

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.

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.

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.

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.

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

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.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

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?

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.

• Is the level of institutional commitment sufficient to provide support for the development of a PBRT research center?
• How convincing/realistic are the provided documents regarding timely construction of the clinical particle beam therapy facility?
• Do the plans include facilities necessary to carry out a broad range of particle therapy-related research, including particle beam delivery systems and dosimetry, radiation biology, translational pre-clinical studies, and clinical trials?
• Will the proposed facility be located in close proximity to a major oncology center to secure access to clinical facilities for the conduct of clinical trials, as well as faculty and staff critical to clinical research?
• Is the proposed research infrastructure adequate to the research plans and the mission of a planned national center for PBRT?

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

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.

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 in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

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

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: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

James A. Deye, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: [email protected]

Jacek Capala, Ph.D., D.Sc.
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: [email protected]

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

Ms. Renee Carruthers
National Cancer Institute (NCI)
Telephone: 301-631-3018
Email: [email protected]

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

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