Required Application Instructions

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

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

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

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 effectiveness of communication approaches and strategies.

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 response to the content of communications. 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. Understanding and responding to risks that affect many may not be as amendable to individual behavior change but to policy change and 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; (iv) the impact of community engagement in developing dissemination strategies; or (v) 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, (ii) who would be the best messenger(s) of information and what media formats work best for specific audiences, and (iii) whether communication or behavioral interventions can identify and address barriers to the 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. Exploring visual mediations of risk (e.g., GIS mapping, animations and gaming approaches that picture risk in non-verbal/non-written formats) thus acknowledges a redefinition of literacy that encompasses the paradigm shift from the centrality of the written word to communications that are based in visual and digital formats. Evaluation of optimal formats (including visual forms of risk communication) is encouraged under this FOA as is evaluation of the most appropriate and effective messengers and how this may vary across audiences and multi-level contexts. Such research can evaluate whether visual representations of risk are easier for individuals with low literacy to understand 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 comprehensibility of 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 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).

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 and/or translate environmental health messages related to breast cancer risks using the R03 and R21 mechanisms. The goals for this initiative are to:

• Conduct research to evaluate the effectiveness of communication strategies suitable for conveying environmental risks for breast cancer to various audiences.
• Adapt, test, and study the dissemination strategies used for risk communication messages from the BCERP toolkits and other existing health risk materials about breast cancer and the environment that are culturally consonant for specific audiences.

The R03 mechanism 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, to understand the role community engagement plays in successful dissemination strategies, or to understand the process for adaptations of existing materials for specific audiences or communities and the effectiveness of dissemination strategies. The R03 mechanism may also be utilized to confirm risk messages are reaching the intended audience using methods from the fields of implementation science, marketing, communications, anthropology, sociology or linguistic research.

The R21 mechanism (RFA-ES-15-017) will support research on the 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/or 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 explore research questions related to the effectiveness of existing communications about breast cancer and the environment risks. 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 fields: communication research, dissemination and implementation research, risk communication (including visualization 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, consultation with breast cancer researchers will be needed to ensure that scientific fidelity is maintained when existing materials are adapted or translated into other languages.

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 the evaluation or adaptation of existing materials on risks of breast cancer from environmental factors. This includes evaluation and exploration of research questions that include but are not limited to the following topic areas:

Content Analysis and Evaluation: Have the most appropriate and validated theoretical frameworks and methodologies been utilized for development and evaluation of risk communications about breast cancer and the environment? Research is encouraged that explores and evaluates

• The effectiveness of various readability tests and other models for evaluating risk messages, or for ascertaining comprehensibility of risk communications in diverse communities
• Approaches for evaluating the efficacy and effectiveness of the BCERP toolkits and other existing resources and tools using validated instruments (e.g., the comprehensibility of existing materials among individuals with low literacy)
• Criteria that community members and organizations can use for recognizing risk messages that are not based in scientific evidence
• Evaluation tools from the fields of risk communication, health literacy, education, anthropology, evaluation research, psychology, and dissemination research to determine which are the most appropriate for communicating environmental risks for breast cancer

Literacy, Perceptions and Beliefs: Should communication strategies aimed to raise awareness and reduce breast cancer risks focus on an individual’s beliefs and perceptions rather than their level of literacy? Research is encouraged that explores and evaluates

• Perception of risk and the role acceptability plays in environmental risk communication, outcome expectancies, action planning, coping planning and/or self-efficacy
• How beliefs may operate differently for breast cancer risks compared to other types of risks
• The development and evaluation of tiered risk messages that reflect various stages of health literacy, e.g., in several versions ranging from non-technical language to increasingly complex scientific explanations of risk.

Cultural Considerations: What role do culture, and acculturation, play in breast cancer and environment risk communication? Research is encouraged that explores and evaluates

• Cultural identity as a factor in determining the format of the health risk message
• The feasibility of targeting risk messaging to specific subpopulations, for various age groups within communities, for different genders, or in various dialects
• The effect of community engagement in designing for dissemination and how community engagement facilitates dissemination i.e., the targeted distribution of information to specific audiences
• The effectiveness of visual communications/visualizations of risk in mixed cultural settings.

Dissemination: What are the optimal approaches for disseminating 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
• The criteria and tools or mechanisms for updating risk messages as well as the tools or mechanisms for capturing new evidence as it becomes available
• Processes to ensure the successful integration of evidence-based risk information or interventions within a particular setting (e.g., clinical setting, community forum, school or family setting)
• Methods for assessing the fidelity of translations with the original research findings as well as characterizing adaptations so that we may understand how these adaptations may affect successful dissemination or implementation.

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 communication practices and validate existing resources 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.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

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

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

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

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

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

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 Trainin
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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.

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

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

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

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

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.

No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

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

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

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.

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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.

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 R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

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?

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?

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

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

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

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

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

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

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

eRA 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Symma Finn, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: [email protected]

Gila Neta, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: [email protected]

Alfonso R. Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7175
Email: [email protected]

Molly Puente, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

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

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