Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
U24 Resource-Related Research Projects Cooperative Agreements
New
RFA-CA-20-049 - New Cohorts to Assess Environmental Exposures and Cancer Risk (CEECR; UG3/UH3 Clinical Trial Not Required)
93.393, 93.399, 93.113
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) will support a Coordinating Center to facilitate coordination across the new Cohorts for Environmental Exposures and Cancer Risk (CEECR) (see UG3/UH3 phased awards supported under companion RFA-CA-20-049). The overarching goal of the CEECR is to support innovative scientific research in new prospective cohorts to address knowledge gaps between environmental exposures and cancer etiology, and the genetic, lifestyle and behavioral factors that modify risk across diverse populations. The Coordinating Center will have several responsibilities, including, but not limited to provide administrative support to the CEECR program, create standard operating procedures and best practices to collect core common data elements and biological samples, facilitate communication across cohorts, provide meeting support, create and maintain the CEECR websites, and facilitate deposition of data to NIH repositories.
While letters of intent are usually requested 30 days before application due date, letters of intent for this FOA are requested by December 15, 2020
January 29, 2021
No late application will be accepted for this Funding Opportunity Announcement.
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.
Not Applicable
June/July 2021
October 2021
January 2022
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) and National Institute of Environmental Health Sciences (NIEHS) solicit applications for a Coordinating Center, which will facilitate coordination among new prospective cohorts (see UG3/UH3 phased awards supported under companion RFA-CA-20-049). The goal of the Cohorts for Environmental Exposures and Cancer Risk (CEECR) is to support innovative scientific research in new prospective cohorts that addresses knowledge gaps in cancer etiology and carcinogenesis process with a focus on environmental exposures.
Applicants responding to the Coordinating Center FOA are expected to familiarize themselves with the companion FOA (RFA-CA-20-049) and the requirements for the UG3/UH3 projects related to the activities and responsibilities required for the Coordinating Center.
The main role of the CEECR Coordinating Center will be the integration of efforts across the CEECR program and the facilitation of research activities. The CEECR Coordinating Center will be expected to do this by communication, coordination, and collaboration across the awarded cohorts, in coordination with NIH program staff, and relevant community-based organizations.
Key Terms for this FOA
CEECR: Cohorts for environmental exposures and cancer risk.
CEECR Program: Refers to the overall NIH funding and stewardship of the program to advance scientific research related to environmental exposures and cancer risk. It comprises the research from the new cohorts, the CEECR Coordinating Center, and NIH program staff.
CEECR Steering Committee: A steering committee will be established to oversee collaborative activities that the funded projects may pursue. The Steering Committee will be comprised of representatives from the CEECR Coordinating Center, funded cohorts, and NIH program staff.
Cohort Study: A longitudinal study that follows a group of people over time to assess the associations between exposures and health outcomes.
Environmental Exposures: For purposes of this FOA environmental exposures refers to all the physical, chemical, and biological factors external to a person, and the related behaviors. However, the focus of the RFA will be on environmental chemical and physical exposures.
UG3 Planning-Exploratory Phase: Two-year Planning-Exploratory Phase is focused on the recruitment of study participants and data collection.
UH3 Implementation Phase: Three- to four-year Implementation Phase (for a total of up to 6 years for both UG3 and UH3 phases) during which time the project should be completed.
Background
The complex nature of human environmental exposures, such as chemical and physical agents presents a challenge to cancer research. New prospective cohorts are needed to address gaps in knowledge concerning cancer effects due to chemical and physical exposures. This FOA will support a Coordinating Center to facilitate cooperation across these cohorts.
Research Objectives and Requirements
The U24 Coordinating Center will operate as supporting infrastructure for the CEECR Program, assisting and supporting the new prospective cohorts under companion RFA-CA-20-049. Applicants responding to the CEECR Coordinating Center FOA are expected to familiarize themselves with the companion FOA (RFA-CA-20-049) and the requirements for the UG3/UH3 projects related to the activities and responsibilities required of the Coordinating Center. The Coordinating Center will be responsible for providing coordinated support to the CEECR program as outlined below.
Main Scientific Responsibilities of the Coordinating Center
The Coordinating Center will be responsible for coordinating activities across the CEECR program including:
Coordinating Center Research Team Expertise and Composition
To fulfill the main responsibilities stated above, the Coordinating Center team will be expected to have appropriate expertise and experience in such areas as:
The composition of the research team for the proposed Coordinating Center must ensure the requisite expertise identified above. In addition, the team should be capable of effective communications and productive collaborations with various stakeholder groups. Therefore, the team is expected to include senior members who have considerable leadership skills and experience in productive collaborations with large research teams and/or multi-stakeholder groups (e.g., cancer consortia, or other health consortia, community-based organizations) in diverse settings (e.g., rural, urban).
Logistical and Administrative Responsibilities of Coordinating Center
In addition to scientific support of the CEECR program, the Coordinating Center must be able to provide logistical and administrative support to each cohort funded under companion RFA-CA-20-049, and other activities, including but not limited to:
Structure of the CEECR Program
The CEECR will include approximately five new cohorts composed of multidisciplinary research teams with community engagement activities (RFA-CA-20-049) and a Coordinating Center (this FOA) to integrate efforts across the individual cohorts. Awardees will also identify shared resources that can support needs across the cohorts and maximize the collaborative nature and impact of the program. Members of the CEECR will be required to participate in the yearly meetings for the exchange of scientific information across the cohorts. The Coordinating Center, in conjunction with NIH staff, will facilitate collaborations among the cohorts and community partners. The CEECR will be governed by a Steering Committee comprised of representatives from the funded cohorts, the Coordinating Center, and NIH program staff.
UG3/UH3 awardees (RFA-CA-20-049) will be required to interact closely with the CEECR Coordinating Center (this FOA), and NIH program staff to advance scientific research related to environmental exposures and cancer risk, as outlined below.
CEECR Governance
The CEECR Steering Committee will be comprised of the PI of each cohort and the Coordinating Center, and NIH program staff. Though the Steering Committee will make recommendations, NIH 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 CEECR Steering Committee are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award.
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.
Need help determining whether you are doing a clinical trial?
NCI and NIEHS intend to commit $0.8 million in FY 2021 to fund one award.
Application budgets are limited to $500,000 direct costs per year.
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 not 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.
The multifaceted research solicited by this FOA requires multidisciplinary teams with expertise driven by the proposed research.
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:
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:
Somdat Mahabir, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6941
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants are required to budget funds for PI(s) for travel to attend two meetings in Bethesda or Rockville, Maryland within the grant period. The purpose of these meetings will be to bring together investigators to share knowledge, progress, and findings, and allow for rapid translation of results.
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 general objectives of the proposed Coordinating Center, the overall approach for achieving these goals, and how the approach will support Research Projects.
Research Strategy: The Research Strategy section must consist of Subsections A to D, as explained below.
Subsection A: Administrative Processes
Subsection B: Common Data Elements
Propose a process for interacting with the CEECR program and the NIH to develop standardized frameworks and measures relevant to environmental exposure assessment from traditional questionnaires and innovative technologies, and biological samples. Include a discussion of:
Subsection C: Supporting Research
Propose a process for supporting CEECR research activities in identifying innovative approaches to study environmental exposures and cancer risk in both the short-term and longer-term.
Subsection D: Data Sharing and Dissemination
Applicants must provide a detailed plan for the facilitation of data and resource sharing from each cohort. The data/resource sharing plans must be consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/). Instructions for Resource Sharing Plans is provided in SF 424 Application Guide. Describe the management and decision-making process that promote data sharing and timeline for sharing, the repository where the data will be located, process for accessing data, any limitations, etc. The plan should include steps for creating standard operating procedures, accessibility requirements, and review process for granting access to the research community, and dissemination of that information.
Letters of Support:
Include letters of support from participating institutions and organizations who must agree to ensure that data from the cohorts is shared.
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:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-definedclinical 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 NCI, NIH. 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.
Significance
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 Coordinating Center demonstrate national leadership and engage all stakeholders in advancing research related to environmental exposures and cancer risk and follow-up among study populations? Have the applicants provided a reasonable plan to share de-identified data and metadata to a controlled-access data repository, either an NIH data repository or repository with equivalent access, and whether data and resources have followed FAIR Data Principles (see https://www.go-fair.org/fair-principles/)?
Investigator(s)
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
Do the personnel have the appropriate breadth of expertise and experience with the multiple types of data and assays in order to facilitate data deposition to repositories? Are the proposed leadership approach, staffing, governance, and organizational structure appropriate for the project? Are the investigators willing to collaborate with the CEECR program awardees and NIH to meet the goals and objectives of this program?
If the Coordinating Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills? Are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of sub-awards, if needed?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA
What is the quality of proposed mechanisms for leveraging novel collaboration and communication strategies? How well does the application indicate creativity and flexibility to innovate on an ongoing basis, particularly in large-scale epidemiology studies?
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
Does the application contain acceptable plans for addressing controlled public access and sharing of data and resources? How well does the proposed approach allow efficient management upkeep of a public website? How well does the proposed approach allow for the Coordinating Center personnel and collaborative tools to enable speedy CEECR research planning and implementation? Are the plans for administrative and logistical support of the CEECR program appropriate and well-aligned with scientific support for CEECR research?
Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects? Is an appropriate plan for workflow with a well-established timeline proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of thecategories 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) Sharing Model Organisms; and (2) 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.
Information regarding the disposition of applications is available 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee 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, Grantees, 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 the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (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 resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
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.
In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.
Additional responsibilities include:
NCI program 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 activity of the awardees. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to, the following aspects:
One or more designated NIH Program staff members acting as Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
Additionally, an NIH 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.
The specific roles of the substantially involved NIH staff members include the following activities:
Areas of Joint Responsibility include:
The CEECR Program Steering Committee will serve as the governing board for the CEECR. CEECR UG3/UH3 awardees funded under RFA-CA-20-049 and the U24 awardee funded under RFA-CA-20-050 will form, together with the NIH, the CEECR Program Steering Committee, which will serve as the main governing board of the CEECR Program.
The CEECR Program Steering Committee will consist of the following voting members:
The CEECR Program Steering Committee will meet as needed via phone conference and in person once every year, at locations selected by the Steering Committee in consultation with the NIH.
The Steering Committee may decide to establish Work Groups for specific purposes. The NIH Project Scientists will serve on such sub-committees, as they deem appropriate.
The main responsibilities of the CEECR Program Steering Committee will include the following elements:
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: one NIH designee and two designees with expertise in the relevant area, chosen by the CEECR Steering Committee. 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 agreementsare 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 threatensubmission 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]
Somdat Mahabir, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6914
Email: [email protected]
Abee Boyles, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241
Email: [email protected]
Referral Officer
National Cancer Institute
Telephone: 240-276-6390
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
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.