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Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)
National Cancer Institute (NCI)

Funding Opportunity Title

Breast Cancer and the Environment Communication Research Initiative (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

RFA-ES-15-017

Companion Funding Opportunity

RFA-ES-15-015, R03 Small Grant Program

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

93.113, 93.399

Funding Opportunity Purpose

This Funding Opportunity Announcement encourages research projects focused on the process of effective communication of research findings about breast cancer and the environment. A central objective of this new initiative is to ensure that risk messaging is designed for dissemination and effectively implemented, and leads to individual behavior change or policy change. The ultimate goal is to provide the development, dissemination, and implementation communication-based prevention efforts to reduce the risk for breast cancer from environmental factors.

Key Dates
Posted Date

November 5, 2015

Open Date (Earliest Submission Date)

January 10, 2016

Letter of Intent Due Date(s)

January 10, 2016

Application Due Date(s)

February 10, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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 2016

Advisory Council Review

October 2016

Earliest Start Date

December 1, 2016

Expiration Date

February 11, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Breast cancer is a complex disease and both genetic and environmental factors contribute and interact with each other to increase breast cancer risk. The identification of different environmental factors that influence breast cancer risk presents a tremendous opportunity to prevent breast cancer. The Breast Cancer and Environment Research Program (BCERP), funded by the National Institute of Environmental Health Sciences (NIEHS) and National Cancer Institute (NCI), has been advancing research to identify risk factors, biological pathways affected by exposures, and social influences on health to inform prevention efforts (http://www.niehs.nih.gov/research/supported/dert/programs/breast-cancer/).

Community engagement is an integral component of the BCERP and the program was therefore designed to maximize the involvement of breast cancer organizations and community partners in all phases of the research. BCERP community partners have worked closely with the researchers to disseminate the research findings and provide individuals at risk, healthcare providers, and the general public, with evidence-based information to promote prevention and to minimize risk. Moreover, the Interagency Breast Cancer and Environment Research Coordinating Committee’s (IBERCC) February 2013 report (http://www.niehs.nih.gov/about/boards/ibcercc/) emphasizes the importance of prevention and provides recommendations about communication efforts to improve prevention at the individual, community, and health system level. Prevention per se primarily occurs when clinical interventions are implemented or, importantly, when the research findings are communicated in a culturally appropriate manner and used in evidence-based messaging to targeted individuals. Such approaches will enable affected individuals and families, health care providers and, in cases where environmental factors affect entire regions, community members and decision makers to better understand the risk factors and act upon the information. While BCERP has also promoted community engagement and research translation, this BCERP FOA will explicitly support research on the effective implementation of communication approaches and/or understanding of multi-level factors influencing behavioral and organizational change.

Communication Research Related to Breast Cancer and the Environment Risk Messaging

Communication research is aimed at elucidating the processes of communication as well as at the validity, readability, comprehensibility, uptake and behavioral response to the content of communications. This FOA is intended to support research on implementation, individual behavioral change or assessment of larger systemic changes in response to environmental health risk messages.

For the purposes of this FOA, we define implementation research as the scientific study of methods to promote the integration of research findings and evidence into healthcare policy and practice or as the basis of individual behavioral change. Such research seeks to understand the behavior of stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based messages. The intent of implementation science and related research is to investigate and address major bottlenecks (e.g. social, behavioral, economic, management) that impede effective implementation, test new approaches to improve health risk messaging, as well as determine a causal relationship between the provision of information and its impact.

In addition, we define behavioral change research as behavioral and/or social science research to evaluate whether communication interventions with high potential impact to improve health-promoting behaviors (e.g., dietary intake, physical activity, or avoidance of environmental risk factors for breast cancer) have been effective. Such research would evaluate the effectiveness of communications targeted to specific age groups (e.g., young girls) and/or communication interventions at the individual, family, social network, community, or population level.

Communication research related to breast cancer risks from environmental factors has the potential to answer questions related to the effectiveness and uptake of either individualized or public health communications about these risks. These types of communications may be distinct as the risk of breast cancer affects individuals when the exposure is related to lifestyle and personal environments (e.g., particulates in indoor air pollution, toxic chemicals in household and personal care products and/or occupational exposures) and is potentially under the control of the individual. However, risks may also be associated with exposures from outdoor air pollution or chemicals in neighborhoods or regional water sources, and understanding and responding to risks that affect many may not be as amendable to individual behavior change but to policy change and/or mitigation of the sources of exposure. In either circumstance, communication research can begin to answer key questions including: (i) the feasibility and relevance of individualized risk messages; (ii) the interplay between group values and individual perceptions of risk; (iii) the suitability of widespread public communications about breast cancer and the environment; or (iv) whether messages delivered in public health or community settings are capable of appropriately conveying the variance in risk among individuals. Such research may also explore (i) whether risk messages that are developed for specific audiences are culturally appropriate in both content and imagery and reflect local cultural norms, or (ii) whether implementation approaches or behavioral interventions can identify and address barriers to the dissemination, uptake, implementation and mobilization to action that can occur after the provision of health risk information.

Further, communication research related to environmental factors is uniquely situated to explore the viability and accessibility of visual representations of risk. There has been a massive cultural shift in how people think and communicate in the 21st century since the widespread uptake of personal computers in the 1990s. Visual expressions of risk (e.g., GIS mapping, animations and gaming approaches that portray risk in non-verbal/non-written formats) add a new dimension to literacy, potentially stimulating additional research questions. Evaluation of such visual forms of risk communication is encouraged under this FOA. Such research can evaluate whether visual representations of risk are easier for individuals with low literacy to understand and act upon than written explanations of risks that often require numeracy skills to interpret. And, since the BCERP has focused on the future risk of breast cancer, research is also encouraged that confirms the accessibility and uptake of risk communications delivered in visual formats as appropriate approaches for communicating such risks to children and teenagers.

Communication research might also address the broader context of risk communication i.e., that available information on environmental health risks is not always based on scientific findings and criteria or health risk rating standards are not commonplace tools like readability standards. Research to date has evaluated what are trusted sources of scientific information but gaps remain in understanding how to inform the public and health professionals about distinctions in scientific evidence, uncertainty, or even about the scientific process and need for replication. In addition, more research is needed to evaluate the effectiveness of community engagement in improving risk communication and/or the effectiveness of breast cancer risk information in the context of other health risk information (e.g., information disseminated to the public about risk factors for obesity, diabetes or other types of cancer with similar recommendations for prevention).

Research Scope

This new research initiative, henceforth referred to as the BCERP Communication Research Initiative, will entail a set of companion Funding Opportunity Announcements (FOAs) to support small communication research grants to assess the comprehensibility of risk messages or the effective implementation of existing environmental health messages related to breast cancer risks using the R03 and R21 mechanisms. The goals for the R21 initiative are to:

  • Conduct research to evaluate the effectiveness of dissemination and implementation strategies and/or behavior change communications suitable for conveying environmental risks for breast cancer to various audiences.
  • Evaluate uptake and behavioral changes based on use of existing risk communication messages from the BCERP toolkits and other existing health risk materials about breast cancer and the environment.

The R03 FOA (RFA-ES-15-015) will support research to validate the content (readability and comprehensibility) of existing messages, to identify criteria for the development or updating of evidence-based risk communications about breast cancer and the environment, or to implement adaptations of existing materials for specific audiences or communities. The R03 FOA may also be utilized to confirm risk messages are reaching the intended audience using methods from the fields of dissemination research, marketing, communications, anthropology, sociology or linguistic research.

The R21 FOA will support research on behavioral uptake of risk messaging and individual behavioral change. The R21 FOA may also be utilized to explore the implementation of existing risk messages and whether such messaging has affected policy change or large scale systemic changes to reduce the sources of pollution that pose a risk for breast cancer.

The BCERP Communication Research Initiative will support studies that are hypotheses driven and that explore research questions related to the effectiveness of existing communications about breast cancer and the environment risks. Hypotheses and approaches should be based on accepted models and frameworks from the fields of implementation research, behavioral change research, or social and behavioral change communications research.

Research related to environmental health risk messaging has previously been siloed in a number of different disciplines with little cross fertilization of methods and approaches. This FOA encourages research that embraces the principles of team science and/or that brings together investigators and community partners in transdisciplinary research teams. Such teams should be comprised of individuals with content area expertise in one or more of the following disciplines: communication research, dissemination and implementation research, risk communication (including visualizations of risk), evaluation research, environmental health sciences, anthropology, sociology, education/health education, nursing/nursing research, public health, policy research, psychology, health literacy/environmental health literacy, and/or marketing research. The research teams should also include the involvement of breast cancer advocates, community partners or breast cancer organizational staff. In addition, expertise in breast cancer research will be needed to ensure that scientific fidelity is maintained when existing materials are evaluated and tested.

Researchers funded through this initiative will be expected to collaborate with investigators and community partners in the overall BCERP program, and participate in relevant BCERP working groups and annual meetings.

Research Questions

Research projects should be related to individual behavioral change or policy changes based on uptake of messaging about environmental risks for breast cancer or should explore effective processes for dissemination and implementation of research findings in real world settings. This includes evaluation and exploration of research questions that include but are not limited to the following topic areas:

Behavioral Uptake/Behavioral Change: What is the best approach to assess the behavioral uptake of risk messaging about future risks of breast cancer? Research is encouraged that explores and evaluates

  • The appropriate focus of behavioral change research. Should it evaluate individual behavioral change (self-regulation, stress reactivity/stress resilience and interpersonal processes) individual lifestyle changes to reduce environmental exposures, or social processes, regulatory and/or policy changes to systemically reduce sources and amounts of pollutants and toxins?
  • Which theories and approaches are best for evaluating social, organizational or policy changes that are based on scientific evidence about environmental risks for breast cancer?
  • Criteria to evaluate behavior change communications related to future risk
  • How uncertainty about who is affected and how they are affected can be conveyed as an actionable risk message
  • Which individuals are the most appropriate for studying behavioral uptake of messages about environmental factors and future risk breast cancer parents and caregivers, pre-pubertal or pubertal girls or women of child bearing age? Should boys and men be included in such research?

Implementation Research: What are the optimal approaches for implementing risk information about breast cancer and the environment? Research is encouraged that explores and evaluates

  • The factors or processes that have been barriers to the widespread use of evidence-based risk information about breast cancer and the environment
  • Methods to enhance the uptake and utilization of evidence-based risk messaging
  • Processes to ensure the successful integration of evidence-based risk information and individual interventions within a particular setting (e.g., clinical setting, school or family setting) or that are most effective for moving breast cancer risk interventions, programs or policies into public health and community based settings.
  • The criteria for updating risk messages as new evidence becomes available
  • Methods for assessing the fidelity of translations with the original research findings as well as characterizing adaptations.

Cultural Considerations: What role does culture play in the implementation of breast cancer and environment risk communications? Research is encouraged that explores and evaluates

  • The role of multi-level contextual factors, such as neighborhoods, schools, family settings, organizations, and cultural identity play in uptake of health risk messages and/or behavioral changes
  • Cultural factors that influence or impede uptake of messages and/or behavioral change
  • Whether beliefs about individual risk operate differently for cancer risks compared to other types of risks?
  • The effective implementation of verbal or visual communications in mixed cultural settings

This FOA is not intended to support development of new information on environmental risk factors for breast cancer or to develop new risk messages or web-based materials.

Ultimately, the research outcomes of the BCERP Communication Research Initiative will help identify and promote implementation and communication practices that effectively translate the findings of research into individual behavioral change, public health strategies, clinical practice, and community initiatives to reduce exposures and breast cancer risk.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimate of $600,000 to fund 2-3 awards..

Award Budget

The combined budget for direct costs for the 2-year project period may not exceed $275,000. No more than $200,000 in direct cost may be requested in any single year.

Award Project Period

The project period may not exceed 2 years.

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

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)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

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.

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Alfonso R. Latoni, PhD
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: alfonso.latoni@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.

The study team must be composed of a) a PD/PI with expertise and experience in communications, education, psychology or other related discipline and b) a breast cancer advocate/organization or community partner. The study team must also involve consultation with researcher(s) with expertise in breast cancer research or environmental health sciences.

Modular Budget

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

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:

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at alfonso.latoni@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

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

1. Criteria

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

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? 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?

Investigator(s)

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

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

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

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

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. 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

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Symma Finn, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: finns@niehs.nih.gov

Gila Neta, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: gila.neta@nih.gov

Peer Review Contact(s)

Alfonso R. Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: alfonso.latoni@nih.gov

Financial/Grants Management Contact(s)

Molly Puente, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@mail.nih.gov

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.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.

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