Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) encourages applications from research partnerships formed by academic and industrial investigators, to accelerate the translation of technologies, methods, assays or devices, and/or systems for preclinical or clinical molecular diagnosis, in vitro imaging or spectroscopy that are designed to solve a targeted cancer problem. The proposed systems may include molecular diagnosis, molecular imaging, spectroscopy, or related research resources. Funding may be requested to enhance, adapt, optimize, validate, and otherwise translate the following examples, among others: (a) current commercially supported systems, (b) next-generation systems, (c) quality assurance and quality control, (d) validation and correlation studies, (e) quantitative imaging, and (f) related research resources. Because applications should be translational in scope, this FOA defines innovation as a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in preclinical or clinical settings. In addition, innovation may be defined as delivery of a new capability to end users. The partnership on each application should establish an inter-disciplinary, multi-institutional research team to work in strategic alliance to implement a coherent strategy to develop and translate their system to solve their chosen cancer problem. This FOA will support clinical trials that test functionality, optimize, and validate the performance of the proposed translational work. This FOA does not intend to support either actual commercial production or basic research projects that do not emphasize translation.

Academic-Industrial Partnerships: A prerequisite for participation in this initiative is formation of an appropriate multi-disciplinary team that includes both academic and industrial scientists, where both parties participate from the beginning in essential translational research effort. The academic-industrial partnership may include any number of participants and organizations necessary to assemble a critical mass of expertise and knowhow for effective execution. The level of participation is expected to vary among the partners as necessary to reach the specific translational research goals proposed. The strategic alliance is expected to combine research strengths, laboratory, and other resources unique to each group to advance the translational research goals as defined in this FOA. Industrial involvement from the earliest translational stages facilitates more efficient transfer of academic intellectual property to the commercial setting. For example, it is likely final outcomes would improve if the investigators chose from the start to adopt medical industry's focus on manufacturability, reliability, and routine use of good laboratory practices (GLP) and good manufacturing practices (GMP). That choice would reduce risk and raise the likelihood of successfully meeting FDA standards and consumer expectations by the time they finish the project. Commercialization of the proposed technologies would be the usual goal, but is not necessarily the only path to sustainable dissemination that is a critical objective of this FOA. Another objective of this FOA is to encourage academic-industry partnerships to work together to more readily overcome barriers in translation than they could working alone. This FOA supports work up to the point of pre-commercial production, but specifically does not support commercial production.

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 either preclinical or clinical settings. Innovation for this FOA is not based on the novelty of the proposed technology or methods, but rather a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting. It is innovative to deliver a new capability to end users.

The academic-industrial partnership application should have a coherent translational research strategy for their proposed technology to address a targeted cancer objective.

Project oriented toward clinical use: If it targets a clinical setting, the application should clearly address the significance of the project for single or multisite clinical research, or its potential clinical utility. Teams proposing clinical projects should include physicians as 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.

Project oriented toward pre-clinical use: If it targets a preclinical setting, the application should address the significance for preclinical research. Translations of technologies to enhance the research performance of existing systems or provide new methods for a targeted cancer research problem are appropriate.

Insight into a future intent to explore transfer of knowledge to human investigations may be included where appropriate, but clearly indicated as separate from the proposed project.

Partnership Structure: The partnership must include at least one lead academic and one lead industrial organization, large or small, among their participating organizations. Partnerships of academics and their affiliated start-up technology companies are allowable so long as financial conflicts of interests will be managed in compliance with Department of Health and Human Services and National Institutes of Health policy as described in 42 CFR part 50.

Each academic-industrial partnership is encouraged to solve its choice of targeted cancer problem within the funding period. 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:

• Development, integration and validation of new molecular diagnosis, molecular imaging or spectroscopy systems, technologies, methods, assays, or devices, related component technologies, molecular diagnostic technology, in vitro imaging methods, image processing methods, and development of informatics tools, e.g., non-stain molecular contrast methods for pathology slide microscopy, such as molecular bond vibrational spectroscopic imaging maps.
• Implementation of research methods on one version or multiple manufacturer's versions of commercial platforms, where appropriate.
• Harmonization of data collection and data analysis across single and/or different commercial platforms to reduce the sources of uncertainty in use of biomarkers or other research areas as required for multi-site preclinical or clinical investigations. These efforts may include development of open computer platforms and open source software tools.
• Development of shared resources, data archives, and other approaches intended to facilitate consensus methods for optimization and validation of emerging technologies and methods. It is understood that many commercial entities develop open source tools to support validation of technologies and such applications are encouraged.

Applications appropriate for this FOA should have the following attributes:

• Contain research partnerships formed by academic and industrial investigators, and any other participants to assure the group has a critical mass of essential skills and knowhow to perform the translational aims proposed.
• Propose to enhance, adapt, optimize, validate, and otherwise 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 pre-clinical cancer research, clinical cancer research, or clinical cancer care.

Research projects that are not appropriate for this FOA

This FOA does not 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.

This FOA does not overlap with SBIR/STTR FOAs, e.g., PA-14-071, PA-14-072, or PAR-14-088, which apply special restrictions on participants and projects.

Applications that address in-vivo imaging studies should apply to PAR 13-169 Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01)".

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)

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

Applicant Organizations

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

• 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept 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, 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.

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. A Senior/Key Person or Other Significant Contributor must be listed for both the academic partner and the industrial partner.

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

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

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

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

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

Academic-Industrial Partnership Translational Research Project: Translational research for this FOA must be goal-oriented and designed to meet performance requirements to mitigate or solve a specific cancer problem in either preclinical or clinical settings. The strategic alliance formed by the partnering institutions is expected have the breadth of expertise necessary to overcome barriers to delivery of new capabilities for use by preclinical researchers, clinical researchers, or health care providers.

Applications oriented toward Clinical Research or Clinical Care Delivery: If the selected problem targets the clinical environment, the application should clearly address the significance of the project for single or multisite clinical research, or potential for clinical utility in the chosen medical care setting, e.g., primary, secondary, tertiary care; high or low resource settings; domestic or foreign. 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.

Applications oriented toward Pre-Clinical Research: If the selected problem targets the pre-clinical cancer research environment, the application should clearly address the significance of the project for mitigation or solution of the selected research problem.

Academic-Industrial Partnership: Co-participation of academic and industrial components is expected from year one of the project, led by a Senior/Key Person or Other Significant Contributor from both the lead academic and lead industrial partner. Each application must include a research strategy that reflects an academic-industrial partnership that is either already ongoing or will be active from the beginning of the project. All the partnering institutions will be required to collaborate on the proposed goals in a manner that would enable the entire joint effort to be administered as a single project. Each partner should have sufficient scientific involvement, and at least one participating investigator with qualifications to lead and share authority and responsibility for the project. The Approach Section is expected to describe a coherent translational plan to deliver emerging or new capabilities for preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting. The Innovation Section is expected to show prospects to deliver an emerging or a new capability to end users.

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

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

• All applications submitted for the January 25, 2015, due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
• 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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

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

For this particular announcement, note the following:

Innovation for this FOA is not based on the novelty of the proposed technology or methods, but is based on a coherent translational plan to deliver an emerging or new capability for preclinical or clinical use that is not yet broadly employed in the preclinical or clinical setting. It is innovative to deliver a new capability to end users.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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 either preclinical or clinical settings? If the selected problem targets the clinical environment, 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; high or low resource settings; domestic or foreign? If the selected problem targets the pre-clinical cancer research environment, does the application clearly address the significance of the project for mitigation or solution of the selected research problem?

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 preclinical researchers, clinical researchers, or health care providers? If the team proposes a clinical project, does it include physicians as key participants for insight in oncology, pathology and/or other clinical science as appropriate to a specific research plan? Is there adequate participation from year one of the project by a Senior/Key Person or Other Significant Contributor from the lead academic and lead industrial partner, among all partners? 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 preclinical or clinical use that are not yet broadly employed in the preclinical or clinical setting? Does it have prospects to deliver an emerging or a new capability to end users?

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?

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 preclinical researchers, 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.

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.

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

As part of the scientific peer review, all applications:

• 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)
Telephone: 301-945-7573
Email: [email protected]

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

Houston Baker, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5908
Email: [email protected]

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

Tiffani Bailey Lash, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]

Eileen W Bradley, D.SC.
Center for Scientific Review (CSR)
Telephone: 301-435-1179
Email: [email protected]

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]

Kwesi Wright, MBA
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4789
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.