National Institutes of Health (NIH)
National Cancer Institute (NCI)
Funding Opportunity Title
Planning for a National Center for Particle Beam Radiation Therapy Research (P20)
P20 Exploratory Grants
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI) of the National Institutes of Health (NIH), 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, 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. It is expected that this effort will result in 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.
January 28, 2013
Letter of Intent Due Date(s)
April 21, 2013; December 21, 2013
Application Due Date(s)
May 21, 2013; January 21, 2014
AIDS Application Due Date(s)
Scientific Merit Review
October 2013; June, 2014
Advisory Council Review
January 2014; October 2014
Earliest Start Date
April 2014; December 2014
(Now Expired October 17, 2013 per issuance of PAR-13-371), Originally January 22, 2014
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.
Part 1. Overview Information
Part 2. Full Text of 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), issued by the National Cancer Institute (NCI) of the National Institutes of Health (NIH), 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 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. It is expected that this effort will result in 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 tissue 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 is 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 January 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.
Applicants responding to this FOA must 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:
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
The OER Glossary and the PHS 398 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.
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
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
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 must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.
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 PHS 398 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:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
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
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive
Room 7W412, MSC 9750
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Tel: (240) 276-6390
Fax: (240) 276-7682
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
Applicants must complete detailed budget using the R&R Budget Component, as well as subaward/consortium budget component(s) as appropriate.
In addition to standard items for this section, provide documentation of the planning and commitments of the PBRT facility. Include essential documents supporting specific items to be described under Research Strategy. It is expected that documents will not exceed 50 pages.
All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:
Specific Aims: The application should include specific aims relevant to establishing research capacity into the design, construction, and operation of a planned particle beam radiotherapy facility. For example, the proposed specific aims may include one or more of the following activities:
Research Strategy: Research Strategy is expected to focus on specific goals 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.
In addition, the applicants shall address the following aspects related to the planned PBRT facility:
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 PHS 398 Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
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
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.
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-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The 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. Such a Center is envisaged to serve as a national research resource. The Center must be planned to operate as a research center adjunct to an independently created and funded, sustainable clinical facility for PBRT.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? 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?
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?
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?
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?
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 project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Research and Development Activities
Facilities and Infrastructure Proposed for PBRT
Access to Required Specialized Resources
Facilities for Basic, Translational, and Clinical Research
For applications Involving a Consortia
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 Human Subjects Protection and Inclusion Guidelines.
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 Human Subjects Protection and Inclusion Guidelines.
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.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
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
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:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
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
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.
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.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
James A. Deye, Ph.D.
National Cancer Institute (NCI)
Jacek Capala, Ph.D., D.Sc.
National Cancer Institute (NCI)
NCI Referral Officer
National Cancer Institute (NCI)
Telephone: (240) 276-6390
Ms. Renee Carruthers
National Cancer Institute (NCI)
Telephone: (301) 631-3018
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.
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