Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Advanced Development of Informatics Technology (U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	Reissue of PAR-12-287
Related Notices	August 18, 2015 - This PA has been reissued as PAR-15-331. September 03, 2014 - See Notice NOT-CA-14-046. Parts 1 and 2 of this funding opportunity have been amended with new language. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 8, 2013 - See Notice NOT-CA-14-007. Notice of Change in Application Due Date. August 12, 2013 - See Issuance of PAR-13-330; Revisions for Early-Stage Development of Informatics Technology (P01).
Funding Opportunity Announcement (FOA) Number	PAR-13-294
Companion Funding Opportunity	PAR-12-286, R01 Research Project Grant PAR-12-289, U01 Research Project Cooperative Agreements PAR-13-330, P01 Research Program Projects PAR-12-288, U01 Research Projects - Cooperative Agreements
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.396
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to invite Cooperative Agreement (U24) applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge in cancer research. An emerging informatics technology is defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. If successful, these technologies would accelerate research in cancer biology, cancer treatment and diagnosis, cancer prevention, cancer control and epidemiology, and/or cancer health disparities. This FOA is one component of the NCI's Informatics Technology for Cancer Research (ITCR) Initiative whose central mission is to promote research-driven informatics technology development. Potential applicants who are interested in early-stage development should consult companion FOAs listed above. Applications that focus on informatics data processing and analysis or mathematical/statistical modeling alone without informatics technology development are not appropriate for this FOA.

Posted Date	August 6, 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)	(New Date December 18, 2013 per NOT-CA-14-007), Originally 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)	(New Date December 18, 2013 per NOT-CA-14-007), Originally 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

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

The purpose of this Funding Opportunity Announcement (FOA) is to invite Cooperative Agreement (U24) applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge in cancer research. An emerging informatics technology is defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. If successful, these technologies would accelerate research in cancer biology, cancer treatment and diagnosis, cancer prevention, cancer control and epidemiology, and/or cancer health disparities. This FOA is one component of the NCI's Informatics Technology for Cancer Research (ITCR) Initiative whose central mission is to promote research-driven informatics technology development. Potential applicants who are interested in early-stage development should consult companion FOAs listed at the end of the current section of the FOA. Applications that focus on informatics data processing and analysis or mathematical/statistical modeling alone without informatics technology development are not appropriate for this FOA.

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 the development lifecycle (prototyping, hardening, enhancement, 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 more advanced 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 cancer research field. Potential applicants are advised to consult with the scientific contact listed under Section VII of this document for appropriateness of submission to this FOA.

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:

• Technology for automation in experiment design and execution
• Technology for automation in data collection
• Technology for data processing and analysis
• Technology for data quality assessment
• Technology for data integration
• Technology for data presentation and visualization
• Technology for text mining and natural language processing
• Technology to advance data compression, storage, organization, and transmission
• Establishing data exchange formats and/or common data elements
• Improving software interoperability and compatibility
• Adapting computational tools for translational, epidemiological, and clinical applications
• Patient-centric laboratory and clinical data coalescence
• Computer-assisted interpretation of experimental results
• Environment for interactive modeling and simulation
• Computational platform for research collaboration
• Technology for performance evaluation of software tools, algorithms, and data collection methods
• Computational tools for interdisciplinary research training

Examples of research projects that are not appropriate for this FOA:

• Projects that are research centric or focus on data collection, data processing, data analysis, and computational modeling and simulation without informatics technology development; and
• Development of technologies that are not computation or informatics based.

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 research-driven informatics technology development to serve the mission of NCI, program priorities will be given to applications that are exceptional in the following aspects: 1) potential impact to cancer research, 2) the level of interaction with collaborators in the cancer research field, 3) the level of innovation, and 4) proposed technology dissemination plan. 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.

• PAR-12-286, "Revisions for Early-Stage Development of Informatics Technology (R01)";
• PAR-12-289, "Revisions for Early-Stage Development of Informatics Technology (U01)";
• PAR-12-290, "Revisions for Early-Stage Development of Informatics Technology (P01)"; and,
• PAR-12-288, "Early-Stage Development of Informatics Technology (U01)"

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Resubmission 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 $500,000 Direct Costs (excluding consortium F&A costs) per year.
Award Project Period	Applicants may request support for up to 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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

Applicants 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

J. Jerry Li, M.D., Ph.D.
Division of Cancer Biology
National Cancer Institute
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]

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.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

Applicants are required to include travel support for an investigator from their research team to attend the annual meeting.

In the application, a travel budget of one to two trips per year to go to these meetings should be included.

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: As the goal of this FOA is to support research-driven informatics technology development to serve the mission of NCI, program priorities will be given to applications that are exceptional in the following aspects: 1) potential impact to cancer research, 2) the level of interaction with collaborators in the cancer research field, 3) the level of innovation, and 4) proposed technology dissemination plan. Funds requested must be used to support informatics technology development instead of research.

Letters of Support: Applicants must include reference letters from collaborators and/or potential users in the cancer research community. These reference letters should provide details on the nature of the proposed interaction/collaboration and describe how the proposed new development will benefit their research.

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 modification:

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:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• Applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The adequacy of software sharing plans will be considered by Program staff when making funding recommendations. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the applicant. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting .

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 are 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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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. 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.

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 products developed under the ITCR Initiative, 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 as needed.

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 is the impact of the existing technology developed previously by the applicant(s)? How significant will the proposed new development be to the cancer research 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?

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? Are there any similar tools that currently exist? What are the advantages over other 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?

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?

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.

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

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; 3) Genome Wide Association Studies (GWAS); and Software Sharing 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:

• 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 to the NCI. 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 National Cancer Advisory Board. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U24 award. Specific responsibilities include:

• he PD(s)/PI(s) will ensure that all software produced by the project are disseminated according to the approved terms consistent with the guideline of the Software Dissemination Plan specified in Part 2. Section I of this document;
• The PD(s)/PI(s) will implement procedures to actively solicit input and feedback from the user community and integrate those into the software development plan;
• The PD(s)/PI(s) will be actively engaged in outreach activities targeting the user community, the cancer research community in particular;
• The PD(s)/PI(s) will participate in all ITCR program activities including its annual meetings, workshops and working groups;
• The PD(s)/PI(s) will seek opportunities of collaboration with other projects of the ITCR Initiative in the aim of producing software tools that are compatible and interoperable in order to maximize their utility;
• The PD(s)/PI(s) will be expected to work closely with the NCI Program Director and Project Scientist (see below) in project coordination and management as described under NCI Staff Responsibilities ;
• The awardee will retain custody of and have primary rights to the software developed under the award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NCI Program Staff, acting as Project Scientists, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Specifically, the NCI Project Scientists will:

• Coordinate and facilitate interactions and collaborations among the awardees of the ITCR Initiative;
• Serve as the liaison between individual projects and other components of the ITCR Initiative including its Advisory Committee;
• Evaluate and approve individual project's Software Dissemination Plan and oversee its execution;
• Provide technical assistance and advice to the awardees as appropriate;
• Assist in avoiding unwarranted duplication of effort with other ITCR projects;
• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- Specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a Cooperative Agreement award for lack of adherence to required policies and/or procedures;
• Participate in organizing ITCR annual meetings and special workshops;
• Develop working groups and trans-project efforts as needed;

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist. In that case, the individual involved will not attend peer review meetings, or will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Areas of Joint Responsibility include:

The NCI Project Scientist and the PD/PI of the Cooperative Agreement awards funded under the ITCR Initiative will be jointly responsible for participating in initiative-wide activities and for establishing inter-project collaborations.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 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 (DCB)
National Cancer Institute (NCI)
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 (NCI)
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 (NCI)
Telephone: 240-276-7028
Email: [email protected]

Asad Umar, D.V.M., Ph.D.
Division of Cancer Prevention (DCP)
National Cancer Institute (NCI)
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 (NCI)
Telephone: 240-276-5956
Email: [email protected]

James Deye, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
Telephone: 240-276-5690
Email: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
Telephone: 240-276-6390
Fax: 240-276-7682
Email: [email protected]

Jackie Boudjeda
Office of Grants Administration
National Cancer Institute (NCI)
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.