Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites applications from research partnerships formed between U.S. and Turkish scientists to aid the development of appropriate affordable diagnostic and therapeutic technologies to address medical needs in low-middle resource settings. Appropriate medical technologies are those that are useable, cost effective, sustainable, and effective in meeting a significant clinical need in a lower-middle resource setting in different world regions.

Collaborations between U.S. and Turkish investigators should be aimed at developing medical technologies that can significantly impact underserved populations within the United States and/or Turkey and potentially populations in other Low and Middle Income Countries (LMICs), particularly in Africa, the Middle East and Eastern Europe. NCI and NIBIB encourage efforts towards developing or reengineering existing medical technologies to make them affordable and efficient so that they will have a significant impact on cancer. The program places special emphasis on the need for medical technologies that will have more translational potential.

Funding may be requested to develop, enhance, adopt, validate, and translate so that the technologies can accomplish cancer risk assessment, screening, detection, diagnosis, treatment or monitor treatment related outcomes. The proposed technology/device should be cost effective and widely applicable in LMICs, and offer capabilities comparable to those available in clinical settings of higher income countries (HICs).

The collaboration must involve at least one U.S. investigator from an eligible U.S. institution and at least one Turkish collaborator affiliated with an eligible Turkish institution. An eligible Turkish institution is either a non-profit or a recognized academic institution as determined by The Scientific and Technological Research Council of Turkey TUBITAK. Applications supported by this program will involve integrated research projects that are enriched by the inclusion of scientific expertise of both U.S. and Turkish institutions. Successful applications will include a well-presented justification for the bilateral collaboration and detailed experimental approaches that will be completed by each country. Research applications should be submitted as a single application by the U.S. institution to the NIH; it is anticipated that the Turkish PD/PI will be submitting a corresponding application to TUBITAK.

The research proposed must involve a collaborative effort between the U.S. PD/PI and a Turkish scientist. Since this is a partnership between U.S. (NIH) and Turkey (TUBITAK) agencies, involving both Dollar and Turkish Lira funding decisions, it is essential that both NIH and TUBITAK receive the identical Research Plan and a description of the relative roles of the U.S. and Turkish collaborators. It is the responsibility of the collaborative team to insure that appropriate application materials are received by the Turkish Secretariat of the program at TUBITAK including all relevant IRB approvals, Material Transfer Agreements (MTA) or other materials as required by TUBITAK.

Development or adaptations of technology to a low cost and user friendly device suitable for resource-poor settings with minimal medical infrastructure face many challenges such as, lack of built infrastructure, no access to health care provider, lack of power lines etc. The rapid development and proliferation of portable devices with significant computational power that can be equipped with various sensors present a great potential for improved technology to expand the current reach of biomedical systems into presently underserved areas. One way to address these challenges is through collaborative biomedical research and collaborative technology development between HICs and LMICs.

The purpose of this FOA is to encourage collaboration between U.S. and Turkish investigators to develop new, affordable diagnostic and therapeutic technologies for lower-middle resource settings, and enable product development and/or technology transfer. The Turkey-US collaborative program application should have a coherent translational research strategy for their proposed technology to address a targeted cancer objective.

The goals of this FOA are to:

• Foster joint activities between U.S. and Turkish scientists on affordable detection, diagnostic and therapeutic technologies.
• Address medical needs in low-middle resource settings, and take advantage of opportunities and technological advances, with the development of appropriate and affordable medical technologies.

To address needs and opportunities, Turkish and U.S. scientists will undertake a coordinated program that will involve collaborative, peer-reviewed research and technology development projects. Collaboration between engineers and scientists in the U.S. and Turkey will be based on mutual benefit, trust, and a shared commitment to development of diagnostic or therapeutic technologies for people in low-resource settings.

Translational Research and Innovation: Translational research for this FOA should be goal-oriented and designed to meet performance requirements for effective dissemination and adoption of the proposed result to solve a targeted cancer problem in clinical settings. Innovation for this FOA is tightly linked to the translational plan to deliver emerging or new capabilities for clinical use vis- -vis novel or reengineered technologies. Innovation will come from capabilities that are not yet broadly employed in clinical settings

Project Oriented Toward Clinical Use:. Teams should include the technology developers working in conjunction with physicians. Physicians are the key participants to provide essential expertise in oncology, pathology and/or other clinical science and practice appropriate to the planned outcome. Research plans that implement, optimize, and validate with multisite clinical investigations are encouraged. However, applications in which a clinical trial is the essence (where the technology and methods have already been adapted, optimized, validated and established, e.g., where the intent is to explore clinical outcomes) are not appropriate for this FOA.

Partnership Structure: The partnership must include at least one lead Turkish and one lead US investigator. Each partnership is encouraged to solve its choice of targeted cancer problem within the funding period. The strategic alliance formed by the partnering institutions is expected to have the breadth of expertise necessary to overcome barriers to delivery of new capabilities for use by clinical researchers, or health care providers. This FOA will support the placement of copies of prototypes in multiple research sites for study and validation of performance.

Possible technologies designed to address a targeted cancer problem as defined in this FOA include, but are not limited to, the following:

• Quantitative tools for monitoring therapy, treatment response, screening for post-therapeutic relapse and pre-clinical models for research;
• Low-cost technologies that help collect robust patient-reported outcomes information to support clinical research efforts;
• Technologies that can be used in conjunction with imaging to improve sensitivity and specificity of early detection, diagnosis, prognosis or treatment of cancer;
• Technologies for risk and survival assessment;
• Low-cost technologies for the collection and stabilization/preservation of patient biospecimens for transport for subsequent diagnostic analysis;
• Low-cost technologies that improve quality, accuracy, reproducibility and reliability of immuno-histochemical diagnosis;
• Low cost technologies for assessment of minimal residual disease;
• Low cost technologies for non-invasive or minimally invasive diagnosis;
• Point-of-care tests and reagents for cancer detection and diagnosis;
• Networked and mobile technologies for diagnostic devices mHealth;
• Appropriate, low-cost diagnostic imaging devices for low-resource settings;
• Non-invasive or minimally-invasive screening, detection and diagnostics technologies (e.g. low-cost imaging, biosensors, microfluidics, and microchip technologies);
• Development of low-cost diagnostic assay kits;
• Low-cost multiplex diagnostic technology platforms;
• Low-cost technologies for drug delivery;
• Developing and testing integrated, portable imaging technologies for monitoring health and as part of point-of-care diagnosis and treatment;
• Developing and testing tools to enhance the visualization and psychophysical understanding of complicated health information on mobile devices with the local cultural context;
• Developing and testing decision support systems to provide guidance and a framework for shared decision-making with medical professionals based on best available evidence;
• Developing and testing networked, citizen-driven approaches to engaging and retaining people in improving their health;
• Developing technology that incorporates telemetry and remote access in the acquisition, analysis and monitoring of biomedical data;
• Developing software and hardware tools for telehealth studies that have broad applications;
• Early stage development of telehealth technologies in specific focus areas;
• Software and hardware tools for telehealth studies that have broad applications.

The examples identified above are intended to be illustrative only. Applicants are encouraged to submit applications for any collaborative technology development or device that would be appropriate for a low-middle resource setting. .

Applications appropriate for this FOA should have the following attributes:

• Contain research partnerships formed by Turkish and US investigators, and other participants to assure the group has a critical mass of essential skills and knowhow to perform the translational aims proposed.
• Propose to develop, enhance, adapt, optimize, validate, and translate a technology, method, assay, device, or system for molecular diagnosis or in vitro imaging or spectroscopy for (a) current commercially supported system, (b) next-generation system, (c) quality assurance and quality control, (d) validation and correlation studies, (e) quantitative methods, (f) related research resource, or (g) other possibilities.
• Propose to mitigate or solve a targeted cancer problem in risk assessment, cancer detection, diagnosis, staging, treatment, and/or treatment monitoring.
• Propose to accomplish substantial progress toward delivery of their translated product as a new capability for use by end users in clinical cancer research, or clinical cancer care.

Research projects that are not appropriate for this FOA

This FOA is not intended to support basic research projects that do not emphasize translational processes of adaptation, optimization, and validation for a targeted cancer problem. An application proposing a biological research problem as its essence, (where the technology and methods have already been adapted, optimized, validated and established) is not appropriate for this FOA.

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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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:

Miguel Ossandon
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]

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

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

This FOA must list at least one Investigator from a U.S. institution as the PD(s)/PI(s), and name the Turkish investigator as a collaborating partner.

Teams proposing clinical projects should include physicians as key participants for insight in oncology, pathology and/or other clinical science as appropriate to a specific research plan.

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should include only budget information for the activities for which they are requesting NIH funds. The NIH will make awards to the U.S. institution while the TUBITAK will make awards to the Turkish collaborator. Do not include budget information for activities requested from the corresponding TUBITAK application through the TUBITAK

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Research Strategy: All applications submitted for this FOA should have the following attributes:

1. Turkey US Partnership Translational Research Project: The Approach Section is expected to describe a coherent translational plan to deliver emerging or new capabilities for clinical use that are not yet broadly employed in the clinical setting. The Innovation Section is expected to show prospects to deliver an emerging or a new capability to end users.

2. Applications oriented toward Clinical Research or Clinical Care Delivery: The application should clearly address the significance of the project for single or multisite clinical research, or potential for clinical utility in the chosen medical care setting, e.g., primary, secondary, tertiary care. Furthermore, applicants are expected to describe the impact of their technology in low resource settings.

3. Turkey US collaboration: The application must include a research strategy that reflects Turkey-US collaboration that is either already ongoing or will be active from the beginning of the project. All the partnering institutions will be required to collaborate on the proposed goals in a manner that would enable the entire joint effort to be administered as a single project. Each partner should have sufficient scientific involvement, and at least one participating investigator with qualifications to lead and share authority and responsibility for the project.

4. Turkey-US collaboration Governance: The application's Research Strategy section must include a section on Governance and Organizational Structure that describes the overall organization, major tasks each partner will complete, and benefits each brings to this alliance to enhance prospects for completing specified translational aims. Describe shared leadership, administration, conflict resolution, and technical, scientific and preclinical or clinical responsibilities where appropriate.

Letters of Support: The application should include a letter of support from the Turkish collaborator indicating:

• That the Turkish scientist is willing to collaborate on the project.
• The role of the Turkish scientist on the project.
• That the Turkish scientist's institution satisfies the qualifying restrictions of TUBITAK.
• That the Turkish scientist will be submitting their application on-time to TUBITAK.

Applications lacking such a letter of support will be considered incomplete and will not undergo peer review.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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). 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

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?

Specific for this FOA: Does the application describe a coherent, goal-oriented translational project designed to meet performance requirements to mitigate or solve a specific cancer problem in clinical settings? Does the application clearly address the significance of the project for single or multisite clinical research, or potential for clinical utility in the chosen medical care setting, e.g., primary, secondary, tertiary care; middle or low resource settings?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Specific for this FOA: Does the proposed partnership have sufficient complementary expertise to effectively manage the steps necessary to execute the proposed translational research? Does the strategic alliance formed by the partnering institutions have the breadth of expertise and environmental support necessary to overcome barriers to delivery of new capabilities for use by clinical researchers, or health care providers in LMICs? Does it include physicians as key participants for insight in oncology, pathology and/or other clinical science as appropriate to a specific research plan? While prior partnerships are not required, is there evidence that the partners can work together effectively and apply a sufficient range of expertise and knowledge to complete the proposed translational project?

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?

Specific for this FOA: Does the application present a plan to deliver emerging or new capabilities for clinical use that are not yet broadly employed in the clinical setting? Does it have prospects to deliver an emerging or a new capability to end users in Turkey or other LMIC?

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?

Specific for this FOA: Does the proposed partnership present a coherent plan to effectively advance translation toward delivery of emerging or new capabilities to solve an important cancer research or clinical problem in Turkey or other LMIC?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

Specific for this FOA: Does the strategic alliance formed by the partnering institutions have the environmental support necessary to overcome barriers to delivery of new capabilities for use by clinical researchers, or health care providers?

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.

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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Miguel R. Ossandon MS
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]

Rao L. Divi, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6913
Email: [email protected]

Luis A. Salicrup PhD
National Cancer Institute (NCI)
Telephone: 240-276-5799
Email: [email protected]

Edward Ramos, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-3715
Email: [email protected]

Syed M. Quadri, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1211
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
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 Part 75.