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

This funding opportunity announcement (FOA) focuses across the lifespan and for those living and spending time in non-traditional settings where exposure to environmental pollutants and toxins may occur. It supports NINR’s mission and research priorities to enhance health promotion and disease prevention; improve quality of life by managing symptoms of acute and chronic illness; and enhancing innovation in order to promote health equity and eliminate health disparities. Nurses, the largest segment of the nation s health care workforce, are well positioned to lead change and the transformation of health care and advance the health of individuals and communities. It is well recognized that nurse scientists lead the way in patient-centered point-of-care, biobehavioral research with a primary focus on health promotion, symptom management, quality of care and quality of life. NINR recognizes the importance of the interplay of behavioral, biological, and environmental determinants in the assessment of health and wellness. Throughout its history, NINR has supported research on new and better ways to manage symptoms of acute and chronic illness, including those associated with environmental exposures. Central to NINR’s mission is the importance of symptom-focused research in order to provide a better understanding of symptoms as well as symptom clusters that will improve clinical management of illness and that leads to more productive lives. For this FOA, the goal of NINR's focus on symptom management and other branches (i.e. wellness and self-management) is to support research that improves the understanding of symptoms and develops new strategies for symptom management that will improve quality of life in the presence of environmental exposures, in non-traditional settings, which may result in acute and chronic illness among children and older adults.

An understudied area that would benefit from interdisciplinary collaborative research (e.g., nurse researchers, environmental/occupational health scientists, community partners, economists, physicians, and toxicologists) is children and older adults living in non-traditional settings where environmental exposures result in health risks, symptoms, and other health conditions/diseases including lower respiratory diseases, chronic obstructive pulmonary diseases, and cardiovascular diseases. By partnering and collaborating with researchers and community partners with similar interests in environmental exposures that result in negative health outcomes across the lifespan, nurse researchers are well positioned to lead research and play a pivotal role in expediting environmental health within nursing science. This FOA encourages applications from institutions/organizations to fill this need. For purposes of this FOA, non-traditional settings, for these populations, include places such as community centers; pre-school and non-traditional school environments (e.g., churches, daycare, home-based schools, dormitories, alternative schools, and playgrounds); child and older adult foster care facilities; older adult day care facilities; half-way homes; assisted living and long-term care facilities. NINR and NIEHS are also interested in studies that examine different approaches to reduce and/or eliminate environmental risks (i.e., limited exposure time) and prevent symptoms across the lifespan for those living or spending large amounts of time in non-traditional settings. Therefore this FOA also encourages research that investigates effective environmental health interventions that reduce or eliminate symptoms associated with environmental exposures in non-traditional settings.

Background

It has been well established that environmental exposures, to common and hazardous pollutants, contribute to the development of many human illnesses including asthma, cancers such as breast and lung, Parkinson s disease, and reproductive disorders in both men and women. The possible association between environmental pollutant exposure and obesity continues to be investigated. Research has led to the development of prevention strategies; health and safety guidelines; and potential treatments for asthma, cardiovascular and pulmonary diseases, cancer, and other environmentally-related diseases. A growing body of research evidence supports the role of indoor and outdoor pollutants in aggravating chronic diseases such as asthma and allergic-type reactions, and suggests that these pollutants have a role in the development of diseases, and symptoms associated with disease(s), and increases in health care costs. Environmental factors have also been associated with an increased number of children diagnosed with attention deficit/hyperactivity disorder (ADHD), pervasive developmental disorder (PDD), autism, and developmental impairment. Chemical stressors may be considered as single chemicals, or as mixtures and aggregates as may be found in consumer products used by children and environments and microenvironments frequented by children. Non-chemical stressors include mediating and modifying factors such as economic deprivation, discrimination, poverty, lack of health care, fear of crime, diet and nutrition, physical activity, psychosocial factors, and the design of the built environment (e.g., settings: home, school, and play areas) from birth through young adulthood. Non-chemical stressors, social and cultural factors, and settings cannot be considered alone, but they may be included as modifier variables to the primary environmental stressor(s). Mathematical models that incorporate children and older adult susceptibility to environmental health hazards are scant and must continue to be developed. Developing and comparing interventions aimed at reducing environmental health risks and symptoms through research focused on treatment or prevention strategies to determine interventions that are most effective in real-world settings, is also important in expanding the knowledge base and improving health. Interventions aimed at reducing environmental risks and symptoms in individuals, families, or communities are starting to be supported. However, few of these interventions have been examined in a systematic way and most have not been evaluated relative to cost analysis.

There is evidence that air pollution, allergens, and environmental toxic exposures are associated with adverse health consequences in adults, and especially older adults. For example, the first American Heart Association report (2004) concluded that short-term exposure to particulate matter (PM) air pollution contributes to acute cardiovascular morbidity and mortality and long-term exposure reduces life expectancy. Moreover, the World Health Organization (WHO) stated that over the last 10 years, there has been a substantial increase in findings that particular matter pollution is not only exerting a greater impact on established health endpoints, but is also associated with a broader number of disease outcomes. A growing body of scientific evidence has linked fine PM (>2.5 m) (PM2.5), particulates derived chiefly from combustion processes in transportation, manufacturing, and power generation, with increased risk of respiratory and allergic diseases such as asthma, chronic obstructive lung disease, chronic rhinitis and cardiovascular disorders such as stroke, cardiac arrhythmia, heart failure exacerbation, and myocardial infraction. Ultrafine particulates (UFPs) (<0.1 m, gaseous co-pollutants), particulates found in ozone, nitrogen oxides (NO2) and pollutants (e.g., traffic), have been linked to increased blood pressure, prothrombotic and coagulant changes, systemic inflammatory and oxidative stress responses, endothelial vasoconstriction and dysfunction, and autonomic imbalance and progression to atherosclerosis. Relative to fine PM (> 2.5), UFPs more readily penetrate indoors, are transported over longer distances, and tend to be more uniform within communities, resulting in highly ubiquitous exposure. As researchers and scientists become more sensitive to the need to focus studies on common and/or hazardous environmental pollutants, consideration must also be given to the unequal distribution of exposure within the population as well as understudied settings where exposure occurs.

Young children are likely to be more susceptible than older children and adults to environmental toxins, pollutants, and chemical exposures because of their immature organ development, rapid physical development, greater surface-to-volume ratios, higher metabolic and ventilation rates, and greater and different physical activities/behaviors. For very young children (i.e., those attending day care and pre-school), environmental risks may also occur because they often explore new objects through a variety of senses including taste which adds additional threats from plastics and the leaching of phthalates. Risk assessment of inhaled toxicants has typically focused on adults, with modeling used to extrapolate dosimetry and risks from lab animals to humans. However, behavioral factors such as time spent playing outdoors and/or having closer proximity to the ground may lead to greater exposure to inhaled and systemic toxicants in children. Research demonstrates that depending on the inhaled agent and the age and size of the child, children may receive a greater internal dose than adults because of greater ventilation rate per body weight or lung surface area. Also, metabolic differences may result in different tissue burdens. Other research has demonstrated that there may be child-adult dosimetry differences for inhaled toxicants that are systemically absorbed. Thus, modeling techniques need to be adapted to children in order to estimate inhaled and systemic dose and risk in this potentially susceptible life stage.

While it is recognized that individuals age differently, gradual changes in cardiovascular and circulatory (e.g., rigidity and dilation of the blood vessels; fibrosis in the conduction system; alteration in cell oxygenation processes); pulmonary (e.g., increased rigidity of the thorax and diaphragm; decreased numbers of alveoli and diffusion ability; decreased strength in breathing/coughing); hematologic (e.g., altered antigen-antibody responses, decreased leukocyte production), immune (decreased T and B cells, slowed immune reaction); inflammatory systems (e.g., alterations in the inflammatory immune cascade; and decline in macrophages, neutrophils and phagocytic activity) in older adults results in increased vulnerability to environmental exposures/pollutants and toxins. These age-related system alterations are further compromised in older adulthood when co-morbid conditions exist. In addition to the above aging system changes, older adults are often unmarried, living alone, have limited informal support, and experience more physical and mental health problems than their age peers who live in traditional home settings. In addition, older adult residents living in low-income housing are particularly vulnerable because they have lower income, may be less educated, suffer more functional impairments, encounter higher levels of stress, relocate more frequently, have higher rates of tobacco and alcohol use, and experience more physical and mental health problems. There is a growing body of research examining the relationship between environmental pollutants and their impact on older adults. However, little research has examined the effects of exposure in non-traditional settings where a growing number of older adults spend their time and/or live.

Regardless of a person’s age, setting/building environmentally-induced health-related symptoms and disorders are multifactorial in origin. Factors for consideration must include building characteristics (e.g., age of the building, water damage and dampness, mold growth and airborne mold spores, and dusts), dose and number of days of environmental exposure, routes of exposure, and current health status (e.g., those with asthma, allergies, or who have immunocompromised health conditions have higher prevalence of building and environmentally-related health symptoms and illness). Because of the increased vulnerability faced by children and older adults to different routes and sources of exposure and levels and length of exposure to environmental risks it is important to gain a more in-depth understanding of: 1) the relationship between environmental exposure factors, symptoms, and health outcomes, and 2) effective strategies that minimize or eliminate environmental health-related risks in children and older adults who spend time or live in non-traditional settings.

As this FOA focuses on pre-school and school-age children it is intended to include healthy children, children with known acute and/or chronic diseases, and vulnerable children including those with disabilities. The intended focus on older adults includes healthy older adults, older adults with chronic illnesses and those with developmental disabilities. This FOA is not intended to focus on research with healthy/unhealthy adults in the workplace or living in traditional settings. For children and older adults, locations include, but are not limited to places such as community centers, pre-school and non-traditional school environments (e.g., churches, daycare, home-based schools, dormitories, alternative schools, and playgrounds), child and older adult foster care facilities, older adult day care facilities, half-way homes, assisted living and long-term care facilities. Specific areas of research interest for this interdisciplinary collaborative research include, but are not limited to, the areas listed below.

NINR examples of topics of interest in the area of wellness, self-management, and symptom-management:

• Address the possible mechanisms by which environmental risks/exposures cause, modulate, or potentiate already existing conditions
• Develop studies conducted in non-traditional settings that evaluate critical windows of susceptibility to environmental pollutants that result in exacerbating or reducing health conditions and their associated symptoms
• Develop mathematical and microsimulation models based on non-traditional settings that incorporate children and older adult susceptibility to environmental health hazards and contaminants and their relationship to symptoms and symptom management
• Develop new technologies, or use existing ones for early biomarkers of symptoms resulting from exposure to environmental pollutants and toxins to test efficacy of approaches to manage symptoms
• Characterize life stage specific environmental exposures (chemical and non-chemical), and related outcomes: in settings of greatest importance for children’s exposures (such as homes, child care centers, schools, and playgrounds) and development of strategies to reduce or prevent adverse exposures in those settings

NINR examples of topics of interest in the area of exposure assessment research:

• Examine the relationship between environmental factors/agents in understudied and non-traditional settings that result in the development of symptoms of acute and chronic disorders/diseases including quality of life
• Develop exposure assessment models for risk levels specific to non-traditional settings
• Develop interventions or adapt existing interventions from other settings to reduce exposure to environmental pollution and toxin exposures in non-traditional settings
• Examine environment exposure and dose-responses of children and older adults in the development of illness and/or disease and their related symptoms
• Examine the effects of known determinants of health (e.g., demographic, socioeconomic, geographic and rural verses urban) on non-traditional environment exposure(s) and health outcomes of children and/or older adults
• Conduct research on different approaches to reduce and/or eliminate environmental risks and symptoms for children and older adults living or spending large amounts of time in non-traditional settings

NIEHS will continue to support and facilitate integrated fundamental, clinical, laboratory, and public health science and examples of topics of interest:

• Identify the harmful influences of environmental exposures and changing environments as well as the protective and nurturing impact of healthy environments on normal physiological function of organs and systems of the fetus/child during gestation/childhood/adolescence
• Determine the mechanisms of vulnerability to environmental stressors of the fetus and young child at all stages of early development
• Consider children’s health from a holistic perspective where the impact of complex environmental exposures may be exacerbated by non-chemical stressors encountered in community settings.

NIEHS will continue to support research that:

• Support chemical stressors that may be considered as single chemicals, or as mixtures and aggregates as may be found in consumer products used by children and environments and microenvironments frequented by children
• Support non-chemical stressors include mediating and modifying factors such as economic deprivation, discrimination, poverty, lack of health care, fear of crime, diet and nutrition, physical activity, psychosocial factors, and the design of the built environment (e.g., settings: home, school, play areas) from birth through young adulthood
• Non-chemical stressors, social and cultural factors, and settings cannot be considered alone, but they may be included as modifier variables to the primary environmental stressor(s)
• Characterization of life stage specific environmental exposures (chemical and non-chemical), and related outcomes:
• In settings of greatest importance for children’s exposures (such as homes, child care centers, schools, and playgrounds) and development of strategies to reduce or prevent adverse exposures in those settings

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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.

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 obtain 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.

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

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

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

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

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

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

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

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, with the following modification:.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow our Post Submission Application Materials policy.

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.

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? Is there a strong scientific premise for the project? 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 those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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.

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 (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Center for Scientific Review 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.

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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://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
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Mary Roary, PhD
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2154
Email: mary.roary@nih.gov

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

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

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

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

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.