and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Cancer Institute (NCI) |
|
Funding Opportunity Title |
Revisions for Early-Stage Development of Informatics Technology (P01) |
Activity Code |
P01 Research Program Projects |
Announcement Type |
Reissue of PAR-12-290 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-330 |
Companion Funding Opportunity |
PAR-12-286, R01 Research Project Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.396 |
Funding Opportunity Purpose |
The purpose of this Funding Opportunity Announcement (FOA) is to invite revisions (formerly called "competing revisions") from currently funded NCI P01 program projects for early-stage development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Initiative, this FOA aims to promote interdisciplinary collaboration in the development of innovative computational methods and informatics approaches that are essential for cancer research on all fronts to accelerate scientific discovery and ultimately translate data into knowledge and clinical practice. Applications that focus on data processing and analysis or mathematical/statistical modeling alone without new technology development are not appropriate for this FOA. |
Posted Date |
August 12, 2013 |
Open Date (Earliest Submission Date) |
October 18, 2013 |
Letter of Intent Due Date(s) |
30 days before the due date. |
Application Due Date(s) |
November 18, 2013; June 18, 2014; November 18, 2014; June 18, 2015, 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) |
November 18, 2013; June 18, 2014; November 18, 2014; June 18, 2015, 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. |
Scientific Merit Review |
March-April 2014, October-November 2014, March-April 2015, October-November 2015 |
Advisory Council Review |
May 2014, January 2015, May 2015, January 2016 |
Earliest Start Date |
July 2014, March 2015, July 2015, March 2016 |
Expiration Date |
June 19, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of this Funding Opportunity Announcement (FOA) is to invite revisions (formerly called "competing revisions") from currently funded NCI P01 program projects for early-stage development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge. Early-stage development is defined for the purpose of this FOA as the initial development or the significant modification of existing tools for new applications. Objectives of this FOA are 1) to promote integration of informatics technology development with hypothesis-driven cancer research and translational/clinical investigations, 2) to promote interdisciplinary collaboration and public-private partnership in informatics technology development and dissemination, 3) to promote data and knowledge sharing and the development of informatics tools to enable data and knowledge sharing, 4) to support initial development of new software or adapting existing software for new applications, 5) to promote interaction and collaboration among funded informatics development projects.
Over the last decade, major advances in biology coupled with innovations in information technology led to an explosive growth of biological and biomedical information. From the genomic revolution and many of its manifestations to recent development in high-throughput high-content screening, biomedical scientists have never before been exposed to research data that are so rich and comprehensive, and yet so massive and complex. This situation provides unprecedented opportunities for rapid discovery. At the same time, it confronts researchers, especially bench biologists and clinicians, with significant challenges to access data, analyze data, and ultimately transform discovery into new knowledge and clinical practice. These challenges are even more prominent in the field of cancer research where complexity and heterogeneity of the disease translate to complex data generation conditions and high data management and analysis overhead, a condition that creates significant barriers to knowledge discovery and dissemination.
The fast growing field of biomedical informatics offers potential solutions to the big data problem. At the intersection of biology, medicine, mathematics, statistics, computer science, and information technology, biomedical informatics involves the development and application of computational tools to the organization and understanding of biomedical information, so that new insight and knowledge can be discerned. There is now general consensus that biomedical research is transforming into an information science, and biomedical informatics is no longer an option but an integral component of all biomedical research. However, there are many challenges to the realization of broad acceptance and sophisticated adoption of information technology in everyday research. Some of the challenges are associated with tools, some are with people. For example, there continues to be the need of user-friendly software tools and informatics support for bench biologists and clinical researchers, especially in association with data generated by emerging high-throughput technologies. In some areas, tool development is disengaged from potential users, resulting in over-building and lack of usage. Another significant challenge is in data sharing and data integration. On top of philosophical and cultural barriers, there are significant technical hurdles. These include lack of common standards for data collection and data exchange, lack of common data elements for data harmonization, high overhead for data storage and dissemination, inadequate tools for annotation, and shortage of computational expertise in biomedical research in general.
Recently, informatics needs and challenges have become a frequent topic of discussion at a number of venues both within and outside of NIH. Some common themes and recommendations emerged from these discussions. These include 1) enhanced support of community-based research-driven informatics technology development; 2) improved mechanism to support software development throughout development lifecycles (prototyping, enhancement, dissemination, and maintenance); 3) sustained effort to promote data sharing and to improve software interoperability; 4) coordinated effort to establish data exchange standards and common data elements; and 5) enhanced training in bio-computing. These critical needs identified by the research community are recognized by NCI and formed the basis in developing the NCI Informatics Technology for Cancer Research (ITCR) Initiative, of which the current FOA is a component that aims at supporting early-stage research-driven informatics technology development.
This FOA encourages applications that involve the development of innovative and user friendly informatics technologies of significant value to the whole spectrum of cancer research from bench to bedside. The emphasis will be on novelty, uniqueness, and potential impact to the parent project and the broader cancer research field. Potential applicants are advised to consult with the Scientific/Research Contact listed in Section VII. Agency Contacts.
The scope of this FOA is limited to informatics technology development. Some examples of the utility of informatics technologies that may be addressed in response to this FOA include, but are not limited to, the following:
Examples of research projects that are not appropriate for this FOA include the following:
Wet-lab based technology development is supported by the NCI IMAT Program. Potential applicants who are interested in the development of molecular technologies are advised to consult with scientific staff of the IMAT Program for suitability of submission.
As the goal of this FOA is to support the development of enabling informatics technologies to enhance research of the parent grants, program priorities will be given to applications that are exceptional in the following aspects: 1) potential impact and utility, 2) the level of integration between the technology component and the parent grant research component, 3) the uniqueness of the proposed technology, and 4) proposed technology dissemination plan. There are no limitations regarding the area of research of the parent grant, but the performance of which will be a factor of consideration in making funding recommendations. Funds requested must be used to support informatics technology development instead of research.
As listed below, there are four additional FOAs issued under the ITCR Initiative that cover additional types of project and support technology development at different stages. Investigators are allowed to submit multiple applications in response to these FOAs given that they are scientifically distinct from each other.
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 |
Revision applications from active NCI P01 awardees 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 |
The amount of requested budget may not exceed $150,000 Direct Costs (excluding consortium F&A costs) per year. |
Award Project Period |
Applicants may request support for up to 2 years, not to exceed the remaining number of years on the parent grant. If a no-cost extension is needed on the parent grant, it must be in place before the revision application is submitted. |
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 noteligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are noteligible 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.
The parent project must be an active NCI P01 project. The PD(s)/PI(s) on the revision must be the same as the PD(s)/PI(s) on the parent grants.
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 can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
J. Jerry Li, M.D., Ph.D.
Division of Cancer Biology
National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, Room 6W336
Bethesda, MD 20892-9747 (for regular mail)
Rockville, MD 20850 (for express delivery)
Telephone: 240-276-6210
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
6 |
Project (Use for Research Project) |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Outline the Specific Aims of the entire P01 Program including the proposed new project.
Research Strategy: The application should first state very concisely the overall goals of the ongoing P01 and summarize the progress made in each funded project and shared resource core. The application should contain sufficient information about the ongoing program activities to permit an adequate evaluation of the requested expansion of the overall P01. Provide the rationale and justification for adding the proposed new project. Explain how it will affect the overall theme, goals, objectives, aims, and research strategy of the ongoing program. Include the relevance of the newly proposed research project to the entire P01; and how the funds will influence the specific aims, research design, and methods of the current grant.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover Research Project
Complete only the following fields:
PHS 398 Cover Page Supplement Research Project
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information Research Project
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Research Project)
List all performance sites that apply to the specific component.
Research & Related Senior/Key Person Profile (Research Project)
Budget (Research Project)
Budget forms appropriate for the specific component will be included in the application package.
Awardees of this FOA are required to attend annual meetings of the ITCR to present progress of their projects. In the application, a travel budget of one to two trips per year to go to these meetings should be included.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Research Project)
Introduction to Application: For Resubmission and Revision applications, an Introduction to the Application is allowed for each component
Specific Aims: Outline the Specific Aims of the proposed new project.
Research Strategy: The proposed projects are expected to focus on early-stage development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge. Address rationale, significance, and approach of the proposed new project following the standard guidelines for research strategy. Interdisciplinary collaborations in the development of innovative computational methods and informatics approaches that ultimately translate data into knowledge and clinical practice are encouraged.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Software Dissemination Plan:
A software dissemination plan, with appropriate timelines, is expected to be included in the Resource Sharing Plan(s) in the PHS398 Specific Research Plan Component to meet the goals of this initiative. Grantees are entitled to limited software copyright protections and institutional software licensing agreements.
There is no prescribed single license for software produced under this FOA; however reviewers will be instructed to evaluate dissemination plans which should be consistent with the following guidelines:
One of the goals of this ITCR funding program is to establish a repository of software developed under this program. Once implemented, funded individual projects will be expected to deposit their software including the source codes and documentations at the repository, allowing centralized access and dissemination, consistent with achieving the goals of this program.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Research Project)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Research Project)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Awardees of this FOA are required to attend annual meetings of the ITCR to present progress of their projects. To maximize the impact and utility of technologies developed under the ITCR, awardees are encouraged to interact and collaborate with each other in the effort to develop interoperable software tools. Periodically, the ITCR may organize special workshops to discuss emerging topics and issues in cancer informatics that require community engagement and input. Awardees will be expected to participate in these activities should they be called for.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030,
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
What will be the value of the proposed informatics technology to the parent project and to the broader cancer research field? Does it enable the parent project to propose new hypotheses, answer new questions, extend the scope to new important areas, generate new knowledge, or allow the project to be conducted with higher efficiency and productivity?
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?
What is the track record of the investigator(s) in technology innovation and dissemination?
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?
How innovative is the proposed technology? Do similar tools currently exist? What is the advantage of the new tool in comparison to competing technologies?
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?
Is there enough flexibility built into the development framework that allows the software to adapt continually to evolving new data, technology, and user requirements, and allows it to be interoperable with other related software tools? Are the proposed timeline and milestones sound and realistic? How closely integrated are the research project(s) of the parent grant and the informatics technology development project in the application?
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.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as currently presented, taking into consideration the responses to the previous review and changes made to the project.
Renewals
Not Applicable.
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
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; 3) Genome Wide Association Studies (GWAS); and Software Dissemination Plan.
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. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Phone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
For general questions about this FOA and specific questions related to cancer biology applications, please contact:
J. Jerry Li, M.D., Ph.D.
Division of Cancer Biology
National Cancer Institute
Telephone: 240-276-6210
Email: [email protected]
For questions related to cancer control and population sciences, please contact:
Mukesh Verma, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute
Telephone: 240-276-6889
Email: [email protected]
Richard P. Moser, Ph.D.
Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
Telephone: 240-276-6915
Email: [email protected]
For questions related to cancer prevention, please contact:
Sudhir Srivastava, Ph.D., M.P.H.
Division of Cancer Prevention (DCP)
National Cancer Institute
Telephone: 240-276-7028
Email: [email protected]
Asad Umar, D.V.M., Ph.D.
Division of Cancer Prevention (DCP)
National Cancer Institute
Telephone: 240-276-7038
Email: [email protected]
For questions related to cancer treatment and diagnosis, please contact:
Laurence (Larry) Clarke, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute
Telephone: 240-276-5956
Email: [email protected]
James Deye, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute
Telephone: 240-276-5690
Email: [email protected]=
Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: 240-276-6390
Email: [email protected]
Jackie Boudjeda
Office of Grants Administration
National Cancer Institute
Telephone: 240-276-6312
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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