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 Nursing Research (NINR)
National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Environmental Exposures and Health: Exploration of Non-Traditional Settings, (R01)

Activity Code

R01 Research Project Grant  

Announcement Type

New

Related Notices

  • June 3, 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-12-133

Companion Funding Opportunity

PA-12-134, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.361, 93.113 

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) issued by the National Institute of Nursing Research (NINR) and the National Institute of Environmental Health Sciences (NIEHS) is to encourage interdisciplinary research aimed at promoting health, limiting symptoms and disease, and reducing health disparities in children and older adults living or spending time in non-traditional settings. These settings result in exposure to environmental pollutants and toxins that result in health risks, symptoms, and other health conditions/diseases including lower respiratory diseases, chronic obstructive pulmonary disease, and cardiovascular diseases. Risk identification and symptom management include prevention and behavior changes and actions to maintain health and prevent disease with an emphasis on the individual, family, and community which will advance nursing science. For purposes of this FOA, non-traditional settings, for children and older adults, 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, and alternative schools), child and older adult foster care facilities, older adult day care facilities, half-way homes,  assisted living and long-term care facilities.    

Key Dates
Posted Date

March 23, 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)

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

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 2016

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

Research Objectives:

Purpose:

This funding opportunity announcement (FOA) issued by the National Institute of Nursing Research (NINR) and the National Institute of Environmental Health Sciences (NIEHS), focuses on children and older adults living or 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 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, that 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, 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 for children and older adults, nurse researchers are well-positioned to lead research and play a pivotal role in expediting environmental health within nursing science. This FOA encourages Research Project Grant (R01) 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, and alternative schools), child and older adult foster care facilities, older adult day care facilities, half-way homes, assisted living and long-term care facilities. NINR is also interested in studies that examine different approaches to reduce and/or eliminate environmental risks (i.e., limited exposure time) and prevent symptoms for children and older adults living or spending large amounts of time in non-traditional settings. Therefore this FOA also encourages comparative effectiveness research to investigate 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. 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 comparative effectiveness research (CER), 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.  Even fewer have examined outcomes associated with usual and customary care or in relation to comparative effectiveness.

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. A growing body of scientific evidence has linked fine particulate matter (>2.5 µm) (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 infarction. Ultrafine particulates (UFPs) (<0.1 µm, gaseous copollutants), 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 (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, 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 (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.

Objectives:

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, and alternative schools), 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 following areas:

Examples of topics of interest in the area Symptom Management Research:

Examples of topics of interest in the area of Exposure Assessment Research

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the 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, with the following modifications:

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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff 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 SF 424 (R&R) Application Guide.

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

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.

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), 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 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:

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)

Karen Huss, PhD, RN, APRN-BC, FAAN, FAAAAI, Program Director, Office of Extramural Activities
National Institute of Nursing Research (NINR)
Telephone: (301) 594-5970
Email: hussk@mail.nih.gov

Kimberly Gray, PhD
National Institute of Environmental Health Sciences
Telephone: (919) 541-0293
Email: gray6@niehs.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)

Lawrence Haller, Grants Management Specialist, Office of Grants Management
National Institute of Nursing Research (NINR)
Telephone: (301) 402-1878 
Email: hallerl@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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NIH Funding Opportunities and Notices



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