EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
Reissue of PAR-10-169 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-169 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.394, 93.395, 93.396 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) encourages applications from research partnerships formed by academic and industrial investigators to accelerate the translation of either preclinical or clinical in vivo imaging systems and/or methods that are designed to solve a targeted cancer problem. The proposed imaging system/methods may include single or multi-modality in vivo imaging and spectroscopy systems, image-guided and drug delivery systems, image analysis, and related research resources. This FOA may also include, as a secondary goal, support for other laboratory imaging or reference methods as required to validate the performance of the proposed in vivo imaging system and/or methods. Funding may be requested to enhance, adapt, optimize, validate, and otherwise translate the following examples, among others: (a) current commercially supported imaging systems/methods, (b) next-generation imaging systems/methods, (c) quality assurance and quality control methods, (d) validation and correlation studies, (e) quantitative imaging methods, and (f) related research resources. Because appropriate applications must be translational in scope, this FOA defines innovation as a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in preclinical or clinical settings. The partnerships on each application should establish an inter-disciplinary, multi-institutional research team to work in strategic alliance to implement a coherent strategy to develop and translate their proposed imaging system/methods to solve a targeted cancer problem. This FOA will support clinical trials that emphasize optimization and validation of the performance of imaging systems, including devices, agents and/or methods. This FOA will not support commercial production, or basic research projects that do not emphasize translational development and optimization of the methods for a targeted cancer problem. |
Posted Date |
April 5, 2013 |
Open Date (Earliest Submission Date) |
May 5, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, 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 |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
May 8, 2016 |
Due Dates for E.O. 12372 |
Not Applicable |
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). 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
This Funding Opportunity Announcement (FOA) encourages applications from research partnerships formed by academic and industrial investigators to accelerate the translation of either preclinical or clinical in vivo imaging systems and/or methods that are designed to solve a targeted cancer problem. The proposed imaging system/methods may include single or multi-modality in vivo imaging and spectroscopy systems, image guided and drug delivery systems, image analysis, and related research resources. This FOA may also include, as a secondary goal, support for other laboratory imaging or reference methods as required to validate the performance of the proposed in vivo imaging system and/or methods. Funding may be requested to enhance, adapt, optimize, validate, and otherwise translate the following examples, among others: (a) current commercially supported imaging systems/methods, (b) next-generation imaging systems/methods, (c) quality assurance and quality control methods, (d) validation and correlation studies, (e) quantitative imaging methods, and (f) related research resources. Because appropriate applications must be translational in scope, this FOA defines innovation as a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in preclinical or clinical settings. The partnerships on each application should establish an inter-disciplinary, multi-institutional research team to work in strategic alliance to implement a coherent strategy to develop and translate their proposed imaging system/methods to solve a targeted cancer problem. This FOA will support clinical trials that emphasize optimization and validation of the performance of imaging systems, including devices, agents and/or methods. This FOA will not support commercial production, or basic research projects that do not emphasize translational development and optimization of the methods for a targeted cancer problem.
The rationale and purpose of this FOA for academic industry partnerships and the strong emphasis on translational research are outlined below, followed by examples of the translational research scope that would be supported by this FOA.
Academic Industry Partnerships: A prerequisite for participation in this initiative is the formation of an appropriate multi-disciplinary team that includes both academic and industrial scientists, where both parties participate in the research effort. The level of participation is expected to vary among the partners depending on the specific research goals proposed. These teams are expected to combine research strengths and laboratory resources unique to each group to accelerate the translational research goals as defined in this FOA. Thus, it is anticipated that an outcome of the research will be a greater understanding and participation by academic and industry scientists in translational research that eventually will enhance the probability of commercial production of the proposed systems/methods, a critical outcome of this FOA. One example would be to bring better understanding of the rigor in medical industry’s use of good laboratory practices (GLP) and good manufacturing practices (GMP) to the academic setting, which could later facilitate more efficient transfer of academic intellectual property to the commercial setting. Thus, this FOA is designed to create academic-industry partnerships to overcome translational research barriers up to the point of pre-commercial production, but specifically does not support commercial production.
Translational Research: The National Cancer Institute established the Translational Research Working Group (TRWG) in 2005 to conduct a discussion with the cancer research community and develop recommendations about how the National Cancer Institute (NCI) can best organize its investment to further translational research. They reached an operational definition of translational research: Research that transforms scientific discoveries arising in the lab, clinic, or population into new clinical tools and applications that reduce cancer incidence, morbidity, and mortality (2007: http://www.cancer.gov/aboutnci/trwg/Order-final-report).
For this FOA, translational research must be goal oriented and designed to meet performance requirements for effective adoption of the proposed technology/methods to solve a targeted cancer problem in either the preclinical or clinical settings. Innovation for this FOA is therefore not based on the novelty of the proposed technology or methods, but rather a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting. It is innovative to deliver a new capability to end users.
This definition of translational research applies to all the example research areas as outlined below:
Translational research for this FOA must be goal-oriented and designed to meet performance requirements to solve a specific cancer problem in either preclinical or clinical settings. Thus, respondent academic-industrial partnerships must clearly outline a coherent translational research strategy for their proposed imaging system/methods (imaging, IGI systems, and/or related component technologies) to address a targeted cancer objective. If they target the clinical environment, the application should clearly address the significance of the project for single or multisite clinical research, or potential clinical utility. Teams proposing clinical projects should include physicians as key participants for imaging, oncology, pathology and/or other clinical science as appropriate to a specific research plan. Research plans that reach a level of maturity and validation to support implementation and optimization of multisite clinical investigations are encouraged. However, clinical trials where the technology and methods have already been established, and where the intent is to explore clinical outcomes, are not supported by this FOA.
The translational goals of preclinical imaging are to enhance the research performance of existing imaging systems or provide new methods for a targeted cancer research problem, and permit an efficient transfer of knowledge to human investigations where appropriate. Teams should include physicians, oncologists, molecular and/or preclinical imaging scientists knowledgeable about the targeted applications. This FOA does not support basic research projects that do not emphasize translational development and optimization of the methods for a targeted cancer problem.
The partnership must include at least one lead academic and one lead industrial organization, large or small, among their participating organizations. Each academic-industrial partnership is encouraged to solve its choice of targeted cancer problem within the five year funding period. This FOA will support copies of prototypes for study and validation of performance across multiple research sites. However it does not support pre-clinical or clinical investigations or trials for which the technology and methods are already established and the intent is simply to explore biological research problems or clinical trial outcomes. This FOA does not support commercial production. This FOA does not overlap with SBIR/STTR FOAs, which apply special restrictions on participants and projects.
The following list includes some examples of appropriate preclinical and clinical research that address development and validation of imaging systems/methods for:
Possible technologies and methods designed to address a targeted cancer problem as defined in this FOA include, but are not limited to, the following:
Possible research resources supported by this FOA might include, for example:
Support for collaborative activities: In the spirit of strategic alliances to meet the objectives of the partnership program, investigators are encouraged, where appropriate, to cooperate with one or more NCI-funded centers, networks or consortia, (e.g., with U01, U54, U24 awardees), to gain the advantages of broader consensus on translational research methods. Support for travel to these research sites is appropriate in the application. Plans to collaborate with FDA and NIST scientists may also be included, where support for research scientists and travel may be permitted.
This FOA will support clinical trials that emphasize optimization and validation of the performance of imaging systems, including devices, agents and/or methods.
All applications submitted in response to this FOA should have the following attributes:
This FOA will not support commercial production. Large-scale basic research projects that are NOT involved in translational development and optimization of the methods for a targeted cancer problem will not be considered appropriate to this FOA.
This FOA complements other translational research initiatives of the Cancer Imaging and Radiation Research Programs, such as the following:
Applicants to this FOA are invited to explore affiliation with the NCI Quantitative Imaging Network, which conducts translational research in imaging.
Investigators seeking to pursue imaging research beyond the scope and requirements of this FOA are referred to the following FOAs:
For a list of updated funding announcements, please visit the NCI Cancer Imaging Program's Funding Opportunities webpage
Researchers who are unclear as to which of the imaging FOAs might be most appropriate for their proposed technology development project are encouraged to contact the Scientific/Research Contacts listed in this FOA.
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 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. |
Award Budget |
Application budgets are not limited, but need to reflect the actual needs of the proposed project. |
Award Project Period |
The total project period may not exceed 5 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
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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:
Applicants must download 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.
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. 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: All applications submitted in response to this FOA should have the following attributes:
Academic-Industrial Partnership Translational Research Project: Translational research for this FOA must be goal-oriented and designed to meet performance requirements to solve a specific cancer problem in either preclinical or clinical settings. The strategic alliance formed by the partnering institutions is expected have the breadth of expertise necessary to overcome barriers to delivery of new capabilities for use by preclinical researchers, clinical researchers, or health care providers. If the selected problem targets the clinical environment, the application should clearly address the significance of the project for single or multisite clinical research, or potential for clinical utility in the chosen medical care setting. Teams proposing clinical projects should include physicians as key participants for imaging, oncology, pathology and/or other clinical science as appropriate to a specific research plan.
Academic-Industrial Partnership: Co-participation of academic and industrial components is expected from year one of the project. Each application must include a partnership and research plan that reflects an academic-industrial partnership that is either already ongoing or will be active from the beginning of the project. All the partnering institutions will be required to collaborate on the proposed goals in a manner that would enable the entire joint effort to be administered as a single project. Each partner should have sufficient scientific involvement, and at least one participating investigator with qualifications to lead and share authority and responsibility for the project.
Academic-Industrial Partnership Governance: The application’s Research Strategy section must include a section on Governance and Organizational Structure that describes the overall organization, major tasks each partner will complete, and benefits each brings to this alliance to enhance prospects for completing specific translational aims. Describe shared leadership, administration, conflict resolution, and technical, scientific and preclinical or clinical responsibilities where appropriate.
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.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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:
Innovation for this FOA is based on a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting. It is innovative to deliver a new capability to end users.
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?
Does the application describe a coherent, goal-oriented translational project likely to deliver robust preclinical or clinical imaging or image guided interventional (IGI) platforms, component technologies, and/or research resources that specifically target a cancer problem? Does the project have prospects for delivery and adoption as a new capability by preclinical researchers, clinical researchers, or health care providers??
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?
Does the proposed partnership have sufficient complementary expertise to effectively manage the steps necessary to execute the proposed translational research? While prior partnerships are not required, is there evidence that the partners can work together effectively and apply a sufficient range of expertise and knowledge to complete the proposed translational 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?
Does the application present a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting? Does it have prospects to deliver a new capability to end users?
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?
Does the proposed partnership
present a coherent plan to effectively advance translation toward delivery of
emerging or new capabilities to solve an important cancer research or clinical
problem?
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?
Do the partnership’s strategic alliances include sufficient academic and industrial environmental support to enhance, adapt, optimize, validate and otherwise advance translation of a solution to their chosen cancer problem?
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.
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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
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Email: support@grants.gov
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process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
Houston Baker, Ph.D.
Cancer Imaging Program
National Cancer Institute (NCI)
Telephone: (240) 276-5908
Fax: (240) 276-7890
Email: bakerhou@mail.nih.gov
James A. Deye, Ph.D.
Radiation Research Program
National Cancer Institute (NCI)
Telephone: (240) 276-5690
Fax: (240) 276-5827
Email: deyej@mail.nih.gov
Miguel Ossandon, M.S.
Cancer Diagnosis Program
National Cancer Institute (NCI)
Telephone: (240) 276-5680
Fax: (240) 276-5826
Email: ossandom@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Nicholas T. Mitrano
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: (301) 496-8785
Fax: (301) 496-8601
Email: mitranni@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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