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	New
Related Notices	October 17, 2013 - This PAR has been expired and reissued as PAR-13-371.
Funding Opportunity Announcement (FOA) Number	PAR-13-096
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), 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.

Posted Date	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)	Not Applicable
Scientific Merit Review	October 2013; June, 2014
Advisory Council Review	January 2014; October 2014
Earliest Start Date	April 2014; December 2014
Expiration Date	(Now Expired October 17, 2013 per issuance of PAR-13-371), Originally January 22, 2014
Due Dates for E.O. 12372	Not Applicable

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:

• 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.

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 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.
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

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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

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:

• 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 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:

• Descriptive title of proposed research
• 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]

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:

Referral Officer
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
E-mail: [email protected]

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:

• The Research Strategy section is limited to 12 pages.

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:

• 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 which underpin the establishment of consortia necessary to create and implement a robust research agenda for a planned facility.

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:

• Availability of funding necessary to build a PBRT facility;
• The proposed time frame for completion of the facility along with elucidation of key milestones;
• Description of a business model that will support sustainable operations without compromising the research and development efforts, including basic research and clinical trials;
• Description of the 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 research infrastructure and organizational capabilities;
• Institutional commitment to support facilities necessary to carry out relevant basic, translational, and clinical research;
• Plans for strong and influential 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.

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 Application Guide.

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 Policy Statement.

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.

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?

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?

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 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

• Are the specific aims relevant to establishing a biomedical research capacity within a multi-particle capable radiotherapy facility?
• Do the proposed research activities aim at providing improvements in the particle therapy facility which will enhance its utility as a national particle beam therapy research resource?
• Will the proposed research activities be synergistic with the available facilities and collaborations?
• Will the proposed research activities promote collaboration and exchange of information and ideas between pre-clinical and clinical researchers?

Facilities and Infrastructure Proposed for PBRT

Institutional Commitment

• Has (have) the applying institution(s) demonstrated success in accomplishing 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.
• Is the level of institutional commitment sufficient to provide support for the development of a BPRT research multidisciplinary center?
• Does the application contain substantial and creative plans necessary to obtain competitive grant support for the operation of planned PBRT research facility?
• Is there 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

• How convincing/realistic are the provided documents regarding timely construction of the clinical particle beam therapy facility?
• Will the applicants have access to adequate funding and referral patterns?
• Will the proposed facility be located 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

• Do the plans include 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

• Is the proposed research infrastructure adequate to the research plans and the mission of a planned national center for PBRT?
• Will the proposed research center become an integral part of a major biomedical research institution, to foster scientific interactions and joint multidisciplinary initiatives?
• Does the plan include efficient use of external and internal advisory bodies for strategic planning, decision-making, and priority setting?
• Does the proposed research infrastructure provide mechanisms to promote an adequate level of effective trans-disciplinary and translational collaborations among the members of pre-clinical and clinical teams of the center?
• Will the research enabled by the planned facility aim at providing major improvements in and understanding of PBRT?
• Will the research activities and structure of the planned center facilitate the participation of other collaborators?
• Will the new center promote collaboration and exchange of information and ideas between pre-clinical and clinical researchers?

For applications Involving a Consortia

• Is there adequate substantiation (or record) of the commitment of the parties to work in concert with one another around large, long-term goals?
• Is the research integrated across partner institutions as evinced by programmatic structure and objectives, joint publications and grants and other trans-disciplinary, cross-institutional activities?
• Is the partnership stable, as evidenced by a history of research integration or the provisions of formalized legal agreements?
• 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 center?
• Are there adequate mechanisms to ensure smooth administration of this project across the institutions?

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.

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 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:

• 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.

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.

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

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)
TTY: 301-451-5939
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]

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