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 Institute of Nursing Research (NINR)

Funding Opportunity Title

Research to Action: Assessing and Addressing Community Exposures to Environmental Contaminants (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-12-153

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113, 93.361

Funding Opportunity Purpose

This Funding Opportunity Announcement encourages applications using community-engaged research methods to investigate the potential health risks of environmental exposures of concern to the community and to implement an environmental public health action plan based on research findings.  The overall goal is to support changes to prevent or reduce exposure to harmful environmental exposures and improve the health of a community.

Key Dates
Posted Date

April 4, 2012

Open Date (Earliest Submission Date)

May 5, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

September 8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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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

Purpose

This Funding Opportunity Announcement (FOA) is part of the National Institute of Environmental Health Sciences (NIEHS) “Partnerships for Environmental Public Health” (PEPH) program (http://www.niehs.nih.gov/research/supported/programs/peph/index.cfm).  The PEPH program supports a variety of research, outreach, and training/educational activities to identify, prevent, reduce, or eliminate environmental exposures that lead to adverse health outcomes in communities. This particular FOA encourages community-engagement projects designed to investigate the potential health risks of environmental exposures of concern to a community and to implement an environmental public health action plan based on research findings. 

This announcement also reflects the National Institute of Nursing Research's (NINR's) ongoing investment in clinical, biological, and translational research programs in many areas, including chronic illness, symptom management, disease prevention, and patient-focused health programs that encourage and enable individuals to become guardians of their own well-being.  These investments are based on the perspective that the science of health encompasses the investigation of multiple health determinants, including environmental factors and its impact on the health promotion and self-management behavior of individuals within their communities.  NINR seeks to support research that promotes health equity and eliminates health disparities by investigating the interplay of behavioral, biological, and environmental determinants of health and wellness for all populations, including underserved and resource-limited communities.

Community engagement (CE) lies on a continuum that reflects the level of involvement of community members, or representatives of community populations, in the research.  This continuum of involvement ranges from community consent to research to full participation and shared leadership of community members in the research design and implementation.  Community based participatory research (CBPR) is a well-known framework for Community Engaged Research (CEnR). 

For the purpose of this FOA, CE connotes full participation of community members in the development of the research questions and research design; in the identification of exposures of concern to that community, suitable cohorts and the specific needs of subpopulations; the translation and dissemination of study results; in the development and implementation of an environmental action plan; and in the development of methods for evaluating the success of the project.  In addition, for the purpose of this FOA, CEnR should entail the involvement of sufficient numbers of individuals to adequately represent all segments of their community.  By the involvement of larger numbers of community members, CEnR can more effectively align with a community’s shared vision and values, create an inclusive environment, nurture collaboration, build community capacity to sustain interventions and implementation plans, and increase health and environmental literacy among those involved.

All studies should be motivated by expressed concerns of a community and the need for scientifically-based information to develop or test the environmental public action component of the project.  The research component of projects may include descriptive research (for example, to characterize  sources of exposures, measure exposure levels, or the prevalence of exposure-related health conditions among members of the community and the community itself), as well as hypothesis-driven studies designed to improve understanding of the exposure-health outcome relationship.  The environmental public health action component may include a variety of training/education, outreach, prevention, or behavioral change activities.  This component should be evidence-based, incorporating knowledge gained through the research component of the project, and targeted towards supporting change that will improve the health of a community or decrease the prevalence of local exposure-related health conditions.   Finally, evaluation is a critical component of PEPH and this FOA.  Each project should implement an evaluation of project processes and, when possible, outcomes.  The evaluation component should provide systematic information that can be used to strengthen the project over the life cycle and to assess the effectiveness and impact of the project.

Background

Protecting the public from environmental health risks requires both the generation of science-based information about exposure occurrences and exposure-health relationships, as well as the translation of such information into actions to reduce or eliminate exposure, prevent disease, and promote health. The distinctive needs of individual communities are key for identifying environmental health problems and devising appropriate disease and exposure prevention or remediation tactics.  Furthermore, by fostering community-researcher partnerships, vital information that has been identified by the community about exposures and disease prevalence can be used by the researchers to identify the linkages between such exposures and disease and to develop preventive strategies to promote health and reduce risk of disease across the populations at highest risk.  Placing an emphasis on CEnR partnerships between community and researcher in environmental public health research also ensures that:   

CE is particularly vital in addressing environmental justice issues.  Environmental justice refers to the need to remedy the unequal burden of exposure and disease borne by socioeconomically disadvantaged persons (e.g. populations defined as minority, low income, and Indian tribes).  Geographic location and socioeconomic status play important roles in environmental exposure of these sub-populations as does multigenerational exposures.  In addition, the lack of resources for early identification of the effects of toxic agents, or the means to address known exposures, may lead to an increased disease burden among people who are economically least able to cope with it.  Research to identify and characterize environmental exposures that disproportionately burden these sub-populations can lead to public health action that will reduce the associated health disparities.  Furthermore, active participation of community members in the formulation of environmental health research questions and in the conduct and translation of research findings can help community members better understand the associated health risks and empower them to make informed decisions or to initiate local activities to prevent ongoing chronic and/or cumulative exposures that disproportionately affect them. 

Objectives and Scope

In 2009, the NIEHS initiated the Research to Action program to bring together environmental health researchers and community members to assess and address environmental public health issues of greatest concern to their communities.  Projects supported under this program are unique in that they employ community-engaged research methods to not only conduct research but also to seamlessly translate research findings into public health action.  Currently funded projects are addressing a variety of environmental health issues and include a diverse set of communities.  A detailed description of currently funded grants under the Research to Action program can be found at: http://www.niehs.nih.gov/research/supported/programs/peph/prog/rta/. This FOA intends to expand the number and scope of projects supported through the NIEHS Research to Action program.  Specifically, this FOA uses the NIH Research Project Grant (R01) mechanism, which is intended to support discrete, specified, circumscribed research projects, in contract to the previous Research to Action FOA which encouraged developmental projects (i.e., R21 applications).  The two main objectives of this initiative, however, remain the same: 1) to conduct research to collect information about environmental health concerns of significance to a community and 2) to develop and implement a strategy to translate and disseminate research findings to community members, public health professionals and/or policymakers to support an action that will ultimately promote the reduction of exposure and reduce the health impact from environmental stressors. 

To meet these stated objectives, applicants should propose community-engaged research projects that incorporate three components - research, public health action, and evaluation.  These three components are discussed further below. 

Community-engagement

All projects should include, at a minimum, one health researcher with a background in environmental research and member(s) of community-based organization(s) (CBOs). The researcher(s) on the project should demonstrate a history of conducting research that explores links between environmental exposures and health.  CBO members involved in the project should demonstrate a history of working directly and regularly with the affected community and provide evidence that they adequately represent the range of interests and concerns of the affected community.   Given the demographics of some communities, this may entail the involvement of more than one CBO, or more than one member of a CBO, particularly if the community is identified through its exposure risk or poverty status and includes members of different racial and/or ethnic sub-populations.

Project teams are also encouraged to incorporate expertise in social science, evaluative methods, and communications and be comprised of and co-developed by, researchers and community members. The projects developed by these partners should be focused on environmental agents or diseases that have been identified by the community as potential or existing public health issues. 

Because participation of the affected community is essential for both the identification of environmental health risks to be studied and formulation of research and translation plans, it is expected that fully incorporating equitable input from both researchers and community members is a priority throughout the entire research process.  The collaboration should be established prior to submission of the application and fully described within.  Furthermore, the partnership between the researcher and CBO(s) should appropriately draw upon the unique strengths that each brings to the partnership.  Applications are expected to include evidence of both strong scientific capabilities and evidence of strong community collaboration, trust, and shared leadership and support.   

All applications should include the following information:

Responsibilities of the research partner and community partner include, but are not limited to, collaborating on (a) identifying the most appropriate research design and methodology, (b) coordinating what information and research questions the proposed study can and cannot provide and address, (c) ensuring research findings are translated effectively into public health action and that project evaluation is implemented across the study period, and (d) helping translate and communicate study findings to community members in appropriate and accessible formats. 

The responsibilities of each partner needs to be clear in the application. For example, specific responsibilities of the community partner may include, but are not limited to, (a) collaborating on identifying the environmental stressors, exposures, and health issue(s) of greatest local importance, (b) representing the community perspective when designing the study and informed consent process to ensure comprehensibility and acceptability, and (c) assisting with interpreting study results. In addition, the researcher's responsibilities may include (a) summarizing the scientific literature on exposure-related health risks to both the scientific community and local community and (b) interpreting study results in light of the current state of evidence. 

For purposes of this FOA, “community” refers to populations and groups affected by, or with a shared interest in, environmental exposures and related health outcomes. Populations may be defined by socioeconomic status, geography, exposure(s), race, ethnicity, gender, age, occupation, religion, sexual orientation, disability, illness, or other health condition. The term “community‐based organization” (or CBO) is broadly defined. The CBO does not need to be a formally recognized organization, such as a non‐profit organization, but should be an established community group(s) or network(s) with a common interest in a particular environmental health concern and that includes representatives of the community.  Of note, the involvement of more than one CBO may be necessary to represent the interests and concerns of all members of the community (e.g., the distinct needs of different age groups or diseases, the cultural constraints related to a particular ethnic or religious sub-population.) 

Given the advanced scope of the NIH R01 mechanism used for this FOA, it is anticipated the community-research partnerships will already be established and that applicants will be able to demonstrate evidence of successful past collaboration such as preliminary data from previous research in the community.  Capacity building activities to develop training and educational programs, or to establish a new community-researcher partnership would not be considered appropriate for this FOA.

Research Component

The objective of this component is to support research that will increase knowledge of how environmental exposures impact health and disease in communities.  This can include descriptive studies intended to increase understanding of exposure levels, sources or prevalence of exposure-related health conditions among the community, or hypothesis-driven studies designed to improve understanding of the exposure-health outcome relationship. A key requirement is that research findings should be used to directly inform a public health implementation action plan.  Furthermore, while it is anticipated that research will entail primary data collection, projects should build upon previous research conducted with the community and existing findings, and may also take advantage of existing data sources if such resources can adequately address the research question(s) co‐developed by the researcher‐community partnership team and produce the new information needed for a public health action plan for implementation and sustainability. 

For purposes of this FOA, “environmental exposure” is broadly defined and can include a variety of environmental contaminants. However, projects should focus on environmental exposures that meet all of the following criteria:

The type of research study proposed should be motivated by existing needs identified by the community and lead to an environmental public health implementation action plan.  Applicants should explain why the research findings to be obtained in the project are vital to support the planned environmental public health action. Specific examples of research topics that are of interest for this FOA include, but are not limited to:

Applications that consider interactions between environmental contaminant exposures and the social or physical environment or infectious diseases (as a potential modifier of the health risk associated with exposure to an environmental chemical) are encouraged.  However, applications that focus on the social/physical environment or infectious disease alone will not be considered responsive to this initiative.

Public Health Action Component

For the purposes of this FOA, public health action includes campaigns, programs, interventions, and policies intended to elicit a change in behavior or practice that will lead to the prevention of disease and disability and promote the health of a population.  Public health action may be targeted at the individual, neighborhood, or community level, or developed as models that have national public health practice application.  Participation of the affected community in identifying the most effective public health action plan is essential.

Examples of environmental public health action include, but are not limited to:

Applicants should develop strategies that translate the findings from the research component of the study to action.  The strategy should be designed to help support or promote action that will result in the prevention or reduction of exposure among community members at the local, regional or national level, ultimately leading to improved health outcomes and quality of life.  Furthermore, applicants should clearly explain how their proposed strategy will lead to action with the community.  Examples of possible public health action strategies include, but are not limited to:

Evaluation Component

Evaluations help community-research partners assess the effectiveness and impact of their projects as well as the factors that led to program success (or failure). In addition, evaluations can supply ongoing, systematic information that strengthens projects during their life cycle.  For this FOA, a summary plan for evaluating the project's processes and outcomes should be included in the application. Evaluations should be designed to reflect program goals and objectives. The plan should describe the evaluation questions to be assessed; evaluation metrics that will be measured to answer evaluation questions; who, when, and how such data will be collected; and how data will be analyzed and incorporated into the ongoing study design. The NIEHS PEPH program has developed an Evaluation Metrics Manual to serve as a resource for PEPH applicants in developing and implementing an evaluation plan for environmental public health research projects.  The complete Evaluation Metrics Manual can be accessed electronically at: http://www.niehs.nih.gov/pephmetrics.

Key areas addressed in the Manual include community-research partnerships, the translation and dissemination of messages based on research findings, education and training, and capacity building.  Applicants are highly encouraged to review the Evaluation Metrics Manual for guidance on development of an evaluation plan proposal or to include evaluation scientific expertise on the study team.  

Examples of potential measures for evaluating the project's processes (activities and outputs) may include:

Examples of potential measures for evaluating the project's outcomes may include:

Applicants are encouraged to involve social scientists in the development of these quantitative and qualitative tools to assess progress and programmatic achievements.  Applications that do not contain an evaluation plan would not be considered appropriate for this FOA..

Applicants are encouraged to implement evaluation during any and all phases of the study. The development and use of a project logic model(s) is also encouraged for evaluation planning (see the Evaluation Metrics Manual, Chapter 7 at http://www.niehs.nih.gov/research/supported/assets/docs/a_c/complete_peph_evaluation_metrics_manual_.pdf for more information on logic models).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs must be less than $500,000 in any year, and need to reflect actual needs of the proposed project.

Award Project Period

The maximum period is 5 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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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, 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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.

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 SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

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.

Overall Impact

Reviewers will provide an overall impact/priority 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(s)/PI(s), 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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/priority score.   

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by an appropriate national Advisory Council or Board.  

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Donna McCloskey, PhD
National Institute of Nursing Research (NINR)
Telephone:  301-594-5971
Email: mccloskd@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

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

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone:  301-594-2807
Email:  wertzr@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 Parts 74 and 92.


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