Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Revisions for Early-Stage Development of Informatics Technology (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • August 12, 2013 - See Issuance of PAR-13-330; Revisions for Early-Stage Development of Informatics Technology (P01).
  • August 6, 2013 - See Issuance of PAR-13-294. Advanced Development of Informatics Technology (U24).
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • March 1, 2013 - See Notice NOT-CA-13-006. Notice of Correction to Section V. Application Review Information and Section VII Agency Contacts.

Funding Opportunity Announcement (FOA) Number

PAR-12-286

Companion Funding Opportunity

PAR-12-289, U01 Research Project – Cooperative Agreements
PAR-12-290, P01 Program Project Grant
PAR-12-288, U01 Research Project - Cooperative Agreements
PAR-12-287, U24 Resource-Related 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 encourage revision applications (formerly called "competing revisions") from currently funded NCI R01 and R37 (MERIT) research 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.

Key Dates
Posted Date

September 20, 2012

Open Date (Earliest Submission Date)

December 22, 2012

Letter of Intent Due Date

30 days before the due date

Application Due Date(s)

January 22, 2013, June 18, 2013, November 18, 2013, June 18, 2014, November 18, 2014, June 18, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July 2013, October-November 2013, February-March 2014, October-November 2014, February-March 2015, October-November 2015

Advisory Council Review

August 2013, January 2014, May 2014, January 2015, May 2015, January 2016

Earliest Start Date(s)

September 2013, March 2014, July 2014, March 2014, 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 SF 424 (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.


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www07.grants.gov/contactus/contactus.jsp.
Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage revision applications (formerly called "competing revisions") from currently funded NCI R01 and R37 (MERIT) research 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.

This FOA will utilize the NIH Research Project Grant (R01) mechanism and targets currently funded NCI R01 and R37 projects with at least one year left at the estimated time of award. Applicants cannot request funds beyond the end date of the parent award.

Background and Rationale

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.

Specific Research Objectives

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 contact listed in Section VII of this FOA for appropriateness of submission to this funding opportunity.

The scope of this FOA is limited to informatics technology development. Some examples of the utility of informatics technologies that may be addressed under this FOA include, but are not limited to, the following:

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

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.

Program Priorities and Special Requirements

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.

A. 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 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 the ITCR program is to establish a repository of software developed. 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.

B. Annual Meeting

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

This FOA versus Alternative Opportunities

As listed below, there are four additional FOAs issued under the ITCR Initiative that cover additional types of projects and support technology development at different stages. Investigators are allowed to submit multiple applications to these FOAs given that they are scientifically distinct from each other.

Section II. Award Information
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 R01 and R37 awardees.
Resubmission (but only of revision applications submitted in response to this FOA).

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards depends on the submission of a sufficient number of meritorious applications.

Award Budget

The amount of requested budget may not exceed $150,000 Direct 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The parent project must be an active NCI R01 or R37 project.  There must be at least 12 months remaining on the project when the application is submitted. The PD(s)/PI(s) on the revision must be the same as the PD(s)/PI(s) on the parent grants.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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
E-mail: jerry.li@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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 Central Contractor Registration (CCR). 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.

Revisions require the same budget format (modular or non-modular) as used in the parent grant. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria

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 impact 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How innovative is the functionality of the proposed technology? Are there any similar tools that 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 close is the integration between the research component of the parent grant and the informatics technology development component in the revision 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? 

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS). FOA-specific issue: Is the Software Dissemination Plan consistent with the guidelines specified in Part 2. Section I. of this document?

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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
E-mail: jerry.li@nih.gov

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
6130 Executive Boulevard, EPN 5100
Rockville, MD 20892
Telephone: (301) 594-7344
Fax: (301) 435-6609
Email: vermam@mail.nih.gov

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
E-mail: srivasts@mail.nih.gov

Asad Umar, D.V.M., Ph.D.
Division of Cancer Prevention (DCP)
National Cancer Institute
Telephone: 240-276-7038
E-mail: Asad.Umar@nih.gov

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
E-mail: lclarke@mail.nih.gov

James Deye, Ph.D.
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute
Telephone: 240-276-5690
E-mail: deyej@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Jackie Boudjeda
Office of Grants Administration
National Cancer Institute
Telephone: 240-276-6312
E-mail: Boudjedaj@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.