Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) intends to support canine clinical studies using immunotherapeutic agents and novel therapeutic combinations together with laboratory correlative studies that seek to describe, characterize and understand the cellular and molecular mechanisms that determine the anti-tumor response (or non-response) in dogs with spontaneous tumors. The clinical studies must include therapeutic modulation of the tumor microenvironment (TME) or must elicit direct immune-mediated destruction of cancer cells. Immunotherapy can be used as a single agent or in combination with radiation therapy, chemotherapy, molecular targeted agents, or other therapies including other immunotherapies. The goal is to create a Canine Cancer Immunotherapy Network (K9CIN) that will include laboratories and canine clinical trial sites. The expectation for this program is that therapeutic agents, specimens, and laboratory and clinical protocols will be shared in order to standardize and validate data generated. A companion funding opportunity (see U24 funding opportunity RFA-CA-21-051) will support a Coordinating Center that will aid in the development, standardization, and conduct of the clinical and laboratory studies, as well as data management and statistical support across the funded U01 sites.
August 27, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 27, 2021 | Not Applicable | Not Applicable | February 2022 | May 2022 | July 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late application will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) intends to support canine clinical studies using immunotherapeutic agents and novel therapeutic combinations together with laboratory correlative studies that seek to describe, characterize and understand the cellular and molecular mechanisms that determine the anti-tumor response (or non-response) in dogs with spontaneous tumors. The clinical studies must include therapeutic modulation of the tumor microenvironment (TME) or must elicit direct immune-mediated destruction of cancer cells. Immunotherapy can be used as a single agent or in combination with radiation therapy, chemotherapy, molecular targeted agents, or other therapies including other immunotherapies. The goal is to create a Canine Cancer Immunotherapy Network (K9CIN) that will include laboratories and canine clinical trial sites. The expectation for this program is that therapeutic agents, specimens, and laboratory and clinical protocols will be shared in order to standardize and validate the data generated. A companion funding opportunity (see U24 funding opportunity RFA-CA-21-051) will support a Coordinating Center that will aid in the development, standardization, and conduct of the clinical and laboratory studies, as well as data management and statistical support across the funded U01 sites.
Background
There is a great need for tumor models in immunocompetent animals that mimic human physiology and disease for preclinical immunotherapy research. Patient-derived xenograft mouse models have been used for immunotherapy research (especially CAR T-cell characterization), but the mouse hosts are immunodeficient, a severe disadvantage for the study of immune effects. Genetically engineered mouse models are immunocompetent, but the tumors do not arise spontaneously, which is distinct from human tumors. Pet dogs develop cancer spontaneously at a high rate. It has been estimated that canine cancers occur at a higher frequency than human cancers (5,300 per 100,000 in canines vs 500 per 100,000 in humans). Additional reasons that canines might be a good model for translation to humans include: shorter lifespan and disease progression; coevolving TME; tumor heterogeneity, course of disease and treatment responses similar to humans; similar environmental hazard exposure to humans; genetic bases of diseases including cancers similar to humans; and flexibility to test investigational agents, even in early or minimal disease states.
Specific Research Objectives and Requirements
Research Objectives of this FOA
An important objective of the NCI is to establish the suitability of canine models to study single and/or combination of immunomodulating agents, ideally with molecularly targeted drugs, chemotherapy, or radiation, for the purpose of translating the canine findings to human studies. The NCI's interest includes studies in canine B-cell lymphoma, osteosarcoma, melanoma, glioma, mammary cancer, bladder cancer and other canine cancers (1) for which sufficient accrual is assured, and (2) where preliminary data exists indicating that an immunotherapy approach will be successful. Priority attributes for desired applications include: combinations of immunotherapy/TME-modulating therapy with other therapies, adoptive immune cell therapies such as CAR T-cell therapies or NK cell therapies, immunotherapy studies that include longitudinal biopsies, correlative studies that include DNA sequencing and transcriptomics, and studies including biomarker development in pet dogs treated with immunotherapeutic agents.
For this FOA, the objective is to establish a network of laboratory scientists and canine clinical trialists to study the anti-tumor effects, including mechanisms of action and immune-related adverse events, of immunotherapy agents and novel combinations of immunotherapy and other modalities in canine patients with spontaneous tumors. An essential goal of these studies will be to determine whether or not canine cancer is a close model of human malignant disease, and if so, whether immunotherapy alone or in combination with other modalities in canine models will inform the design of therapies in humans.
Requirements of this FOA
Applications in response to this FOA should address both:
Studies that use antigenic vaccines as monotherapy or in combination with other therapies are also responsive to this initiative. Agents used for proposed studies may be obtained from collaborating pharmaceutical companies or academic institutions that are developing and producing canine-specific immunotherapeutic agents, or from the investigator's own laboratory where agents such as antibodies, small molecules with immunomodulating effects, miRNAs, T-cell therapies, and vaccines, are being developed. In all applications, attention should be paid to dosing, scheduling, and the character of immune-related adverse events in the overall effect of agents and combinations used in the clinical trials.
Studies that, in addition to a clinical trial, use specimens to compare the immunological response of subtypes of a particular canine cancer with similar subtypes of human cancer are also appropriate.
Academic scientists who have had experience working with canine models may apply to this FOA and/or veterinary oncologists who are associated with one of the veterinary medical institutions that are part of the Comparative Oncology Trials Consortium (COTC), which is overseen by the NCI Center for Cancer Research's Comparative Oncology Program (COP). However, participation of a COTC site is not mandatory, if a strong justification for the involvement of a non-COTC site is provided. In addition, the application may also include industry partners that will provide materials, agents, and assays for the studies.
Once funded, a U01 awardee will be required (through a companion U24 Coordinating Center funding opportunity, RFA-CA-21-051, that includes NCI staff) to collaborate with other funded U01 holders in order to increase accrual, standardize clinical and laboratory protocols, and share data, reagents, and specimens as appropriate. Clinical and correlative data resulting from the award that will be published must be submitted to the NCI Integrated Canine Data Commons, a node of the Cancer Research Data Commons.
Structure and Governance of the K9CIN
The K9CIN will include approximately five U01 teams and a Coordinating Center to integrate efforts across the individual sites. Awardees will also identify shared resources that can support needs across the sites and maximize the collaborative nature and impact of the network. The Coordinating Center (companion FOA: RFA-CA-21-051), in conjunction with NCI staff, will facilitate collaborations within the network. The K9CIN will be governed by a Steering Committee and all awardees must be willing to serve on the Steering Committee (SC). The SC will have representatives from the funded U01 sites, the Coordinating Center, and NCI program staff and will meet via monthly teleconferences. Annual face-to-face meetings are also appropriate. Though the Steering Committee will make recommendations, NCI Staff will have final authority to approve any proposed recommendations, and activities must comply with NIH, DHHS, and Federal Guidelines.
Additional details on the composition and functions of K9CIN Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award.
Non-Responsive Applications
The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NCI intends to commit $2,850,000 in FY 2022 to fund five awards.
Application budgets may not exceed $375,000 in direct costs (excluding sub-award F&A costs) per year and must reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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.
Number of Applications
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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
Connie Sommers, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7187
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.
R&R or Modular Budget
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:
Specific Aims: Outline the hypothesis/hypotheses being tested and the specific aims of the proposed project.
Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.
Sub-section A. Significance and Preliminary Data
After providing background information for context, describe the significance of the proposed research plan, including the scientific premise, as it relates to comparative oncology. Describe how the hypothesis and potential results of the proposed studies--both clinical and laboratory--address the long term goal of establishing the suitability of canine models to study immunotherapy agents and novel combinations of immunotherapy and other modalities; and establishing whether canine cancer research will inform the design of human cancer studies, particularly with respect to immunotherapy. Also include (1) a description of earlier studies (published or not) that have led to the proposed clinical trial and (2) information or data from preliminary studies that address the feasibility of the project.
Sub-section B. Approach and Timeline
Describe in detail the proposed Research Project that includes (1) one or more clinical trials in canines with spontaneous tumors treated with immunotherapy as described above under Scope of this FOA and (2) one or more clinical correlative laboratory studies (using biopsy, surgical and/or liquid specimens from the clinical trial) that seek to describe, characterize, and understand the cellular and molecular mechanisms that determine the anti-tumor response (or non-response) in dogs with spontaneous tumors. With respect to responders, correlations with the immunological mutational load (neoantigens) or specific mutations (e.g., mismatch repair and other mutations), or changes to the tumor microenvironment would be valuable, as would evidence that combination modalities increase the immunological mutational load and make the subject more susceptible to immunotherapy.
The approach proposed, including the canine clinical protocol(s) and the associated laboratory studies must be sufficiently and carefully detailed with rigor and transparency aspects addressed for:
A timeline of the initiation and completion of the specific aims should also be included. The innovative aspects of the planned studies should be described, as well.
In applications that include multiple institutions (particularly in separate geographical areas), descriptions of the logistics involved in carrying out the proposed aims to completion within the project period (how tasks that require various and sequential expertise, and how information sharing will be coordinated) must be included.
Subsection C. Participation in K9CIN and Data Sharing
It is important, as well, for this application to discuss willingness to participate in the network Steering Committee and how the U01 will make use of the Coordinating Center (U24) and the Steering Committee in their roles of facilitating the clinical studies including accrual, standardizing the clinical and assay protocols, sharing specimens, assays, and data as appropriate. The application should also address willingness to contribute data to the NCI Integrated Canine Data Commons (ICDC).
Letters of Support: Applicants may collaborate with industry partners or other laboratories that will provide assays or canine-specific or other agents for the canine clinical trials or correlative studies. Letters of support from these entities will be required.
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 and responsiveness by the NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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? Is the prior research that serves as the key support for the proposed project rigorous? 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 to this FOA
How well does the research proposed in canines inform the design of human cancer studies, especially with respect to immunotherapy? How suitable is the canine model for studying immunotherapy approaches with single agents or combination agents or strategies?
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 to this FOA
If appropriate, are collaborators studying human disease included and how valuable are these collaborations?
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 to this FOA
How applicable are the proposed innovations to human cancer research?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA
How compelling and relevant are the preliminary data or published results for the proposed approach? How realistic is the timeline for the proposed approach? How available are the therapeutic agents proposed for use in canine clinical trials and correlative strategies? How statistically sound and realistic are clinical trial accrual goals? How appropriate is the proposed plan for sharing agents, specimens and protocols within the network during the project period and how consistent is the proposed plan for achieving the goals of the network?
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 to this FOA
How suitable is the scientific environment for participation in a collaborative network?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:
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 recipient'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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility for the project as a whole resides with the awardees, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NCI staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s) will coordinate in a centralized fashion various activities of the awardees. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to, the following aspects:
Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
The K9CIN Steering Committee will serve as the initiative’s main governing board of the K9CIN. The Steering Committee will be jointly established by the PDs/PIs from each K9CIN-U01 awardee site, the PD/PI from the companion K9CIN-U24 Coordinating Center, and NCI-designated staff members. The K9CIN Steering Committee will provide strategic coordination for cross-site activities.
Voting members of the K9CIN Steering Committee will include:
Non-voting members of the K9CIN Steering Committee will include NCI Comparative Oncology Program (COP) members as Project Collaborators. NCI COP Project Collaborators may advise U01 and U24 scientists regarding canine clinical trial design and data interpretation and may assist in sufficient accrual of canine subjects for study. Additionally, the K9CIN Steering Committee may decide to add non-voting members as needed, e.g., associate members and/or scientific experts.
The K9CIN Steering Committee will formulate strategic decisions and policies for network-wide activities. The K9CIN awardees will be required to accept and implement these decisions and policies to the extent consistent with applicable grant regulations. All Steering Committee decisions and recommendations that require voting will be based on a majority vote. The PD/PI of the K9CIN-U24 Coordinating Center will serve as the chair of the Steering Committee. The Steering Committee will meet monthly by teleconference. Annual face-to-face meetings are appropriate.
Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Connie Sommers, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7187
Email: [email protected]
Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7603
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
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.