Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title
New Cohorts for Environmental Exposures and Cancer Risk (CEECR; UG3/UH3 Clinical Trial Not Allowed)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type

New

Related Notices

  • October 21, 2020 - Pre-Application Webinar for RFA-CA-20-049 and RFA-CA-20-050. See Notice NOT-CA-21-006.

Funding Opportunity Announcement (FOA) Number
RFA-CA-20-049
Companion Funding Opportunity

RFA-CA-20-050 - New Cohorts for Environmental Exposures and Cancer Risk (CEECR) Coordinating Center (U24 Clinical Trial Not Allowed)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.399, 93.113

Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) invite applications to support innovative scientific research in new prospective cohorts that addresses knowledge gaps in cancer etiology and carcinogenesis processes with a focus on environmental exposures.
Applicants are encouraged to use validated and reproducible innovative techniques to measure environmental exposures relevant to the proposed scientific research questions. The cohorts should include racial/ethnic minorities and understudied populations to address the unequal burden of cancer that currently exists in those populations. In this FOA, environmental exposures refer to physical, chemical, and biological factors external to a person, and related behavioral factors.
This FOA is published in parallel with RFA-CA-20-050 “New Cohorts for Environmental Exposures and Cancer Risk (CEECR) Coordinating Center (U24 Clinical Trial Not Allowed)”. New prospective cohorts and the Coordinating Center funded under these FOAs together will constitute the Cohorts for Environmental Exposure and Cancer Risk (CEECR) program.

Key Dates

Posted Date
October 14, 2020
Open Date (Earliest Submission Date)
December 29, 2020
Letter of Intent Due Date(s)

While letters of intent are normally requested 30 days before the application due date, for this FOA they are requested by December 15, 2020

Application Due Date(s)

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2021

Advisory Council Review

October 2021

Earliest Start Date

September 2021

Expiration Date
January 30, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) invite applications to support innovative scientific research in new prospective cohorts to address knowledge gaps between environmental exposures and cancer risk across diverse populations, accounting for relevant factors that may interact with environmental exposures. Applicants are encouraged to use validated and reproducible innovative technologies to assess exposures and outcomes as relevant to the proposed scientific aims.

It is anticipated that the new cohorts will provide scientific evidence related to environmental exposures and cancer risk.

The CEECR program will support UG3/UH3 phased award research projects (under this FOA) and a U24 Coordinating Center (companion RFA-CA-20-050).

Applicants in response to this FOA must apply for both the UG3 and UH3 phases together in the single application. The UG3 Planning-Exploratory Phase is focused on the recruitment of study participants and data collection, and the UH3 Implementation Phase is focused on completing the research agenda. UH3s will be awarded pending administrative review of eligible UG3s that have met the scientific milestones necessary for the UH3 phase, depending on the availability of funds. Recruitment is not required to be completed in the UG3 phase, but reasonable progress should be demonstrated to ensure that all aims will be completed in the UH3 phase. Although studies may differ, the UG3 phase is up to 2 years, whereas the UH3 phase will be up to 4 years (for a total of up to 6 years). Successful awardees from this FOA will work with the NCI, other CEECR awardees, and the CEECR Coordinating Center. For details on the CEECR Coordinating Center (U24), see RFA-CA-20-050.

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.

CEECR Coordinating Center: Includes the coordinating center funded through the companion RFA-CA-20-050.

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

Humans are exposed to a multitude of chemical agents/mixtures as indicated by CDC’s biomonitoring program and these exposures vary by demography and geography (https://www.cdc.gov/exposurereport/chemical_selection.html. The complex nature of human exposures to chemical and physical agents presents a challenge to research in this field. This complexity can be attributed, in part, to the numerous mixtures in the environment, fluctuations in dose over time, and different routes of exposure. Gaps remain in our understanding of cancer risk and the mechanisms of carcinogenesis resulting from chemical and physical exposures, including the assessment and impact of exposures throughout biologically relevant time periods and life stages. In addition, the health effects of exposures to the multitudes of chemical mixtures humans experience are poorly understood. Advancements in methodologies to investigate complex, dynamic exposures throughout human life are providing new opportunities to address these research gaps.

The goal of this initiative is to address gaps in knowledge of the effect of environmental exposures on the risk of cancer through prospective cohort designs leveraging technological advances to measure exposures. Advances in technologies enable capture of a wide variety of exposures and offer an unprecedented opportunity to understand the contribution of environmental exposures to cancer etiology, especially in the most vulnerable populations. This RFA is to support new cohorts that use innovative strategies and approaches to addressing knowledge gaps between environmental exposures, and cancer development, taking into consideration potential confounding and modifying factors, in the most appropriate populations and during relevant time periods or windows of susceptibility.

The changing trends in cancer incidence, in addition to data from a variety of studies, including migration studies, ecological studies, case-control, and prospective cohort studies indicate significant contribution by environmental factors to the cancer burden. Between 2002 and 2017, cancer incidence rates decreased 0.9% and mortality rates by 1.5% on average per year, but with differences by sex, racial/ethnic group, and cancer type. However, there are notable statistically significant increasing trends in both incidence and mortality for some cancers. Among males, incidence rates increased for liver, melanoma, kidney, oral cavity and pharynx, and pancreas. Among females, incidence rates increased for liver, melanoma, corpus and uterus, myeloma, pancreas, kidney, breast, and oral cavity and pharynx. Among children younger than 15 years, cancer incidence rates increased 0.8% on average per year between 2012 and 2016, and among adolescents and young adults, 15 to 39 years of age, cancer incidence rates increased 0.9% on average during the same time period.

Research Objectives and Requirements

This FOA aims to address gaps in knowledge and build upon emerging findings related to environmental exposures and lifestyle, behavioral, genomic or other factors that modify the impact of exposures on cancer risk by establishing new cohorts, especially in understudied and underserved populations. The new cohorts should consider innovative designs to address both short and longer-term questions and also leverage technological advances to measure exposures. Applicants must identify the scientific gap(s) that the study addresses as well as the potential public health impact of the research.

Applicants responding to this FOA are expected to familiarize themselves with the companion FOA (RFA-CA-20-050) for the CEECR Coordinating Center. As the UG3/UH3 awardees will interact closely with the CEECR Coordinating Center, the applicants responding to this FOA need to understand the role and responsibilities of the CEECR Coordinating Center, as well.

Requirements for the CEECR (Cohorts)

This initiative calls for research questions that can be addressed in both the short-term and longer-term with prospective observational study design. Consideration should be given to the use of validated intermediate markers of cancer outcomes as well as longer-term cancer outcomes. Cancer outcomes must be validated through linkage to population-based cancer registries and/or medical records or pathology reports.

Applicants are strongly encouraged to include underserved and understudied populations to address scientific gaps in knowledge related to environmental exposures and cancer risk.

Awardees are expected to work collaboratively across the cohorts and with the CEECR Coordinating Center and NIH Program Staff to establish an agreed-upon core set of data to be collected across the cohorts.

The sample size and proposed data collection must be driven by the scientific questions proposed. The collection of biological samples and the frequency of collection should be guided by the proposed research.

Applicants are encouraged to consider the incorporation of data through linkages to relevant exposure data from available databases. Linkages to relevant registries such as Virtual Pooled Registry Cancer Linkage System (VPR-CLS) funded by NCI and Human Health Exposure Analysis Resource (HHEAR) co-funded by NCI will enable cost-effective approaches to both exposure and outcome assessment.

Applicants are also expected to include details of community engagement activities designed to inform research, enhance recruitment and retention efforts, and disseminate results. Applicants are expected to have meaningful engagement with key stakeholder groups throughout the process from study design, through the conduct of the study, to communication and dissemination of results. In particular, there are special concerns including trust and data ownership when conducting research in vulnerable populations. There needs to be an awareness of local culture and belief systems. The budget should accommodate support for community engagement activities. Community partners may be representatives of advocacy, support or research organizations; community leaders; liaisons to Native American, Latino or African American populations; community health workers, etc. The community partner(s) should be skilled in outreach, education, social work, or public health. The partnership between the research scientists and the community partners is to draw upon each of their respective strengths, allowing for the integration of their unique perspectives and expertise into informing research priorities. The partnership should also facilitate bi-directional communication between researchers and the engaged community over the course of the research study.

Study Must Include:

  • Scientific justification of the research gap to be addressed in both exposures and outcomes.
  • Evidence of validity and reproducibility of proposed exposure assessments and outcome measures.
  • Scientific justification of relevance if the impact of exposure in cancer risk is addressing a window of susceptibility.
  • Evidence of community engagement in the development and conduct of the proposed research.
  • Justification of the study population and sample size given the proposed science.
  • Willingness to collaborate on a core set of data related to environmental exposures and cancer etiology.
  • Demonstration of innovation and novelty in addressing proposed research questions.
  • Description of critical milestones, performance metrics, and a timeline for completion of milestones.
  • Description of the sustainability and preservation of cohort resources that extend beyond the life of the award.
  •  Detailed data/resource sharing plans that are consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/) for Resource Sharing Plans as provided in SF 424 Application Guide.

Applications must describe the management and decision-making process that promotes data sharing and the timeline for sharing, the repository where the data will be located, the process for accessing data, any limitations, etc. Applicants are required to provide broad access to the data through controlled-access data repositories. This FOA requires the deposition of data to an NIH data repository.

Sample Research Questions:

Examples of short-term research questions

  • How do environmental exposures affect biological markers of the carcinogenic process (for example, DNA damage/repair, epigenomic markers, etc.)?
  • How do point-of-contact exposure assessment methods (for example, personal monitoring technologies, etc.) explain variability in biomarker measurements (for example, individual biomarkers, various targeted and untargeted markers, etc.)?
  • How are classes of environmental chemicals such as per- and polyfluoroalkyl substances (PFAS) and endocrine-disrupting chemicals or mixtures of chemicals distributed in understudied populations?
  • How do chemical mixtures affect key carcinogenic hallmarks such as metabolic activation and induction of chronic inflammation?
  • How do persistent organochlorine compounds impact molecular markers of carcinogenesis and cancer risk?

Examples of longer-term research questions

  • What are the associations between classes of chemical exposures and cancer risk among racial/ethnic groups?
  • What is the impact of air pollution on cancer development in urban versus rural populations?
  • How do categories of chemical mixtures in the blood change over time and what is the cumulative impact on cancer risk?

Additional Requirements:

  • Awardees are required to submit to NCI quarterly accrual reports and descriptive data, including counts of participants (current age, vital status, and response rates).
  • Awardees are required to contribute cohort information to a cancer epidemiology cohort descriptive cohort database (CEDCD) (https://cedcd.nci.nih.gov).
  • If applicable, investigators are expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources for the collection, processing, and storage of biospecimens (https://biospecimens.cancer.gov/bestpractices/).
  • Applicants will be required to budget for annual meetings at NIH during the award period where awardees will discuss their progress, measures, and methodologic work. Additional webinar meetings will take place throughout the award period.
  • Successful applicants will function within the CEECR program. Grantees will work together to develop a core set of questions that will be required to be included within data collection tools across cohorts.
  • Awardees will be required to comply with all NIH and the CEECR Program requirements related to data and resource sharing.
  • Awardees must establish community partnerships that will strengthen the reach, rigor, and relevance of proposed science important to their communities.
  •  Awardees are required to share de-identified data and metadata to a controlled-access data repository, either an NIH data repository or repository with equivalent access. Data and resources must follow data and resources following FAIR Data Principles (see https://www.go-fair.org/fair-principles/).

UG3/UH3 Mechanism

The UG3/UH3 mechanism has two phases: the UG3 Planning-Exploratory Phase focused on the recruitment of study participants and data collection, and the UH3 Implementation Phase focused on completing the research agenda. Milestones to be accomplished in the UG3 phase for the transition to the UH3 phase will be proposed by the PD/PI in the application and will require NCI/NIEHS review and approval before the grant is awarded and must include a timeline for recruitment and data collection. Recruitment is not required to be completed in the UG3 phase, but reasonable progress should be demonstrated to ensure that all aims will be completed in the UH3 phase. Although studies may differ, the UG3 phase is expected to be up to 2 years, whereas the UH3 phase will be up to 4 years (for a total of up to 6 years).

Successful applicants will work together with the NIH and other awardees to identify key core data elements that should be collected in all the funded cohort studies. The feasibility of meeting the proposed recruitment and/or data collection milestones stated in the application is critical for the UG3/UH3 transition phase. All proposed milestones will be included in the terms of awards and will be monitored closely by the NCI/NIEHS. To initiate the transition from UG3 to UH3, the applicant will submit a detailed transition request to proceed to the UH3 implementation phase. UH3 transition requests will undergo administrative review by NCI/NIEHS staff to determine whether the study will be awarded the implementation phase (UH3). Transition decisions will be based on achievement of study milestones, readiness to conduct the UH3 study, the feasibility of completing the UH3 study, availability of funds, and program priorities. Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 implementation phase. Successful completion of UG3 milestones is required to transition to the UH3 award.

Criteria for Transition to UH3

To meet the research goals of the CEECR program, the research applicants/awardees will be expected to have:

  • Successful achievement of proposed UG3 Planning-Exploratory Phase milestones;
  • Met recruitment goal timelines to enroll participants and demonstrate the feasibility to collect and analyze data as determined by agreed-upon UG3 milestones;
  • Participated in CEECR Steering Committee, activities of the CEECR Coordinating Center (see parallel RFA-20-050), and other collaborative activities of the CEECR program as needed, and established community engagement activities.

Transition to UH3 will also be dependent on the availability of funds and NCI program priorities.

Structure of the CEECR Program

The CEECR will include approximately five new cohorts composed of multidisciplinary research teams with community engagement activities and a Coordinating Center 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 yearly face-to-face meetings for the exchange of scientific information across the cohorts. The Coordinating Center (companion FOA: RFA-CA-20-050), in conjunction with NIH staff, will facilitate collaborations among the cohorts. The CEECR will be governed by a Steering Committee comprised of representatives from the funded cohorts, the Coordinating Center, and NIH program staff.

Awardees will be required to interact closely with the CEECR Coordinating Center, and NIH program staff to advance scientific research related to environmental exposures and cancer risk, as outlined below.

  • Scientific Interactions with CEECR Coordinating Center: Each cohort will collaborate with the CEECR Coordinating Center as required to develop common data elements and, as appropriate, share protocols for the collection of biological specimens.
  • Scientific Interactions with CEECR Steering Committee: The CEECR Steering Committee will establish CEECR Work Groups intended to provide a forum for discussing and advising on topic areas that overlap all CEECR research from the cohorts. Members of the CEECR Work Groups will include investigators form each cohort, CEECR Coordinating Center, and NIH Program Staff.

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.

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.

  • Approaches that do not include human populations;
  • Approaches that are based on secondary use of existing cohort data;
  • Approaches that use a study design that will not lead to a prospective cohort;
  • Applications from foreign countries that do not show direct relevance to the U.S. population (applications for foreign countries are eligible but must show relevance to U.S. populations); and
  • Non-compliant data/resource sharing plans and not following FAIR principles.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed
New

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.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI and NIEHS intend to commit $6.5 million in FY 2021 to fund approximately five awards.

Award Budget

Application budgets are limited to $750,000 direct costs per year in years 1 and 2. Budgets in years 3-6 are not limited but must reflect the actual needs of the proposed project.

Award Project Period

The proposed project period for the initial development phase (UG3) must not exceed 2 years and the total duration of the UG3/UH3 phases combined may not exceed 6 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Somdat Mahabir, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6941
Email: mahabir@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Applicants are required to budget funds for PD/PI(s) for travel to attend an annual grantee meeting 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. In addition, the budget of the UG3 phase cannot exceed $750,000 in direct costs per year. There is no specified budget cap for the UH3 phase; however, budgets must reflect only the work necessary to complete the aims and are subject to available NCI and NIEHS funds.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Provide the overall goals for the entire application and indicate separately Specific Aims to be accomplished in the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase.

Research Strategy: Applicants must organize the Research Strategy into the subsections identified below. Applicants may include other sections as needed but must include the information requested below.

Sub-section A. Background and Significance

  • Provide an overview of relevant scientific literature.
  • Identify the novel scientific gap fulfilled by the proposed projects.
  • Justify and explain rationale for selection of the study population/geographic regions.
  • Explain how the findings of the project will inform future cancer prevention strategies, interventions, public health guidelines to decrease the cancer burden of people in the United States.

Sub-section B. Preliminary Data

  • Summarize preliminary data that demonstrate ability to recruit the selected population of interest, collect and use high-quality data, and work collaboratively in a transdisciplinary team.
  • Summarize preliminary data on the proposed assessments as validity and reproducibility.
  • Summarize history of collaboration with proposed stakeholders, including but not limited to patient advocacy groups, healthcare organizations, community-based organizations, health systems, clinics, health departments, and professional organizations.

Sub-section C. Cohort Description

  • Provide an overview of the study population selected.
  • Describe how the participants of the study will be recruited and retained in the cohort.
  • Specify whether the study participants represent understudied populations based on racial/ethnic groups, geography, or socioeconomic status.
  • Include a description of community engagement.

Sub-section D. Approach (may be divided into the UG3 Phase and the UH3 Phase)

  • Describe methods that will be used to accomplish Specific Aims.
  • Describe the information to be collected in the study.
  • Describe proposed measures of relevant exposures and outcomes appropriate that will ensure high-quality data using validated methods and instruments and evidence-based approaches.
  • Describe the analytic plan, including calculations for sample size and power analyses for all aims.

Sub-section E. Milestones and Timelines

A timeline (including milestones) is required for the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase. The timeline and milestones should reflect overall objectives of each phase. Milestones should be well-defined and include objective criteria for success. Annual milestones should function as indicators of a project's progress and will be used to evaluate the application in peer review and in consideration of funding for the project in non-competing award years. Timelines must include metrics for assessing progress for both phases, including specific milestones for progressing from the UG3 Planning-Exploratory Phase to the UH3 Implementation Phase. Milestones and timelines should be provided under separate headings at the end of the 'Approach' section for the UG3 Planning-Exploratory Phase to the UH3 Implementation Phase subsections. The following are particularly important:

  • Detail recruitment goals;
  • Provide appropriately detailed criteria by which milestone achievement will be assessed;
  • Provide a detailed timeline for the anticipated achievement of each milestone and overall goal;
  • Identify any impediments that could require a revision to the research plan, milestones, and/or timeline along with a discussion of alternative approaches.
  • Provide detailed timelines that are aligned with the overall objectives of each phase: the UG3 Planning-Exploratory Phase focused on recruitment and data collection (including specific milestones that will serve as criteria for progressing to the UH3 Implementation Phase), and the UH3 Implementation Phase focused on completing the research agenda. Include plans for reducing attrition rates.
  • Provide detailed methods for the proposed study, including target sample size (accounting for reasonable estimates of attrition based on prior related studies or published literature), power analyses, justification for unit of analysis, consideration of clustering effects on sample size calculations and analytic plan, timeline for data collection.

Subsection F: Data Sharing and Dissemination
Applicants must provide a detailed plan for the facilitation of data and resource sharing from each cohort after each wave of data collection. 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 Plan is provided in SF424 Application Guide. Describe the management and decision-making process that promotes 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.
 

Health Disparities. If applicable to the type of research being proposed, address how health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

Letters of Support: Applicants must include letters of support from collaborating entities that are essential to the mission of the work proposed.

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:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
  • Applicants must propose a data sharing plan that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable),
Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information

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.

Delayed Onset Study

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.

PHS Assignment Request Form

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

Foreign Institutions

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

Applications will be assigned a single impact score for the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase. Awardees are required to share de-identified data and metadata to a controlled-access data repository, either an NIH data repository or repository with equivalent access. Data and resources must follow data and resources following FAIR Data Principles (see https://www.go-fair.org/fair-principles/)

Overall Impact

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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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 for this FOA

Have the investigators explained how the findings of the project related to environmental exposures will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States?

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?

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 for this FOA

How well does the application, if applicable, describe the representation of understudied and diverse populations?

Approach

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 for this FOA

How well does the approach address both the short-term and longer-term research questions proposed by the investigators? How do the proposed plans for the collection of a core set of data and biological specimens, if any, support the aims of the study? Evaluate the adequacy of the community engagement approach outlined in the application. Does the application contain acceptable plans for addressing controlled public access and sharing of data and resources?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

UG3/UH3 Milestones

How clearly are the steps and milestones defined? Are the milestones feasible and quantifiable with respect to proposed objectives? Are adequate criteria provided for the UG3 Planning-Exploratory Phase to determine the successful completion of milestones? How appropriate are the milestones for the UH3 Implementation Phase?

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

Additional Review Considerations

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) 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.

2. Review and Selection Process

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to 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.

2. Administrative and National Policy Requirements

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

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.

Cooperative Agreement Terms and Conditions of Award

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:

  • Defining the overall research objectives;
  • Determining approaches, designing protocols, setting project milestones, and overseeing the conduct of the research in both the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase;
  • Overseeing the conduct of the UG3/UH3 CEECR research and ensuring its scientific rigor;
  • Ensuring compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
  • Adhering to the NIH policies regarding intellectual property, data release, and other policies that might be established during the CEECR program;
  • Submitting updates to the CEECR Coordinating Center and the NIH on progress and problems;
  • Participating as voting member(s) of the CEECR Steering Committee;
  • Implementing guidelines and procedures developed by the CEECR Steering Committee;
  • Participating in teleconferences with NIH program staff, as needed;
  • Attending CEECR Committee meetings to be held in the Bethesda, Maryland area;
  • Retaining custody of and have primary rights to the data, technologies, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies;
  • The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the UG3/UH3 award in accordance with the terms of the award.

NIH program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NIH program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion various activity of the awardees. Specific responsibilities of the NIH Project Scientist(s) will include, but will not be limited to, the following aspects:

One or more designated NIH Program staff members will have substantial involvement as Project Scientist(s) for the CEECR.

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 responsibilities of substantially involved NIH Program Staff members will include the following activities:

  • Participating as voting members in the CEECR Steering Committee;
  • Advising on innovative approaches for sharing results from the CEECR to key stakeholder organizations (e.g., professional societies, community engagement groups) in user-friendly formats (e.g., briefs, summaries) that extend beyond the traditional peer-reviewed publications or scientific conference presentations;
  • Participating in teleconferences with the PDs/PIs and key personnel of CEECR research to monitor progress;
  • Providing scientific input on the CEECR, including assessment tools, core set of data collections, core set of biological samples, methodological and statistical considerations; participant recruitment, enrollment, and retention; and data analysis and interpretation of study findings;
  • Attending Program Steering Committee meetings to be held in the Bethesda, Maryland area;
  • Participating in CEECR Work Groups;
  • Contributing, as appropriate, to scientific manuscripts and other scientific and scholarly activities (e.g., oral presentations, poster presentations) resulting from the CEECR;
  • Facilitate collaborations between the awardees and other NIH-sponsored programs investigators, or organizations;
  • Assisting with the coordination of efforts that may contribute to the projects’ goals;
  • Organizing and participating in webinars with PDs/PIs to monitor progress and facilitate cooperation;
  • Monitoring progress of the projects towards meeting milestones and adherence to the strategic goals of the program; and
  • Stimulating interactions among awardees.

Areas of Joint Responsibility include:

The CEECR Steering Committee will serve as the governing body for the CEECR. CEECR UG3/UH3 awardees funded under RFA-CA-20-049 and theU24 awardee funded under RFA-CA-20-050 will form together with the NIH. The CEECR Steering Committee will serve as the main governing body of the CEECR.

The CEECR Steering Committee will consist of the following voting members:

  • The PDs/PIs from each cohort UG3/UH3 award (one vote per cohort);
  • The PDs/PIs from the CEECR Coordinating Center (one vote for the CEECR Coordinating Center); and
  • The NIH-assigned Project Scientist(s) who collectively will have one vote.
  • A representative from the community partners who will have one vote.
  • A Chair of the CEECR Steering Committee will be selected at the first meeting. He/she will serve a term of 12-months.

The Steering Committee will meet as needed virtually or 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 Steering Committee will include the following elements:

  • Addressing and coordinating aspects relevant to CEECR research and the CEECR Coordinating Center;
  • Developing, as needed, overall policies and processes applicable to all CEECR awardees;
  • Assisting in dissemination across the CEECR of policies and processes that enable research on environmental exposures;
  • Attending meetings to review progress across the CEECR;
  • Coordinating scientific writing groups for manuscripts and oral and poster presentations at professional societies and scholarly meetings;
  • Establishing CEECR Work Groups; and
  • Stimulating and coordinating communications among awardees, e.g., to share ideas, discuss solutions to technical issues, resolve logistical problems, etc.

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.

3. Reporting

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

A final 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Somdat Mahabir, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6914
Email: mahabir@mail.nih.gov
 

Abee Boyles, Ph.D.
National Institutes of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241
Email: abee.boyles@nih.gov
 

Peer Review Contact(s)

Referral Officer
National Cancer Institute
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: jenny.greer@nih.gov
 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


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