Part 1. Overview Information

Key Dates

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

One in five adults in the United States, nearly 45 million people, suffer with mental illnesses, including prevalent disorders such as major depression and anxiety as well as less common disorders such as schizophrenia and bipolar disorder. The public health burden is immense, accounting for over $300 billion in disability-associated costs per year, as well as societal costs from the loss of work productivity, divorce, suicide, accidents and accidental drug overdoses. In addition to those individuals who meet strict diagnostic criteria, many more suffer from subclinical psychiatric traits and symptoms, in keeping with the evolving conceptual framework of continuous variation of psychiatric traits across the general population. Against this backdrop, there is an urgent need to identify modifiable risk factors that can lead to the development of strategies to prevent or reduce the population burden of psychiatric disorders and related disabling symptoms.

Over the past twenty-five years, the NIEHS has developed and sustained a strong base of epidemiologic and mechanistic research to understand how environmental exposures affect brain function. A robust body of work has demonstrated links between developmental exposures and cognitive and psychiatric outcomes in early childhood (e.g., autism spectrum disorder, intellectual deficits). A separate line of research in aging populations has revealed exposure-related risks for various cognitive and neurological impairments (e.g., Parkinson's disease, cognitive decline). In contrast, research on environmental contributors to brain health in late childhood, adolescence and early adulthood, when clinical symptoms of many psychiatric disorders emerge, has lagged. This gap is particularly compelling when considering that adolescents and young adults experience higher rates of mental illness than other age groups.

Recent trends in understanding how environmental exposures impact the neurobiology of psychiatric disorders

Most psychiatric disorders exhibit moderate to high heritability, with a complex underlying genetic architecture reflecting the contribution of many common and rare genetic variants. Genetics alone provides an incomplete account of individual vulnerability, however, and there is increasing recognition that the environment contributes to risk and expression of these disorders. In addition to well-established findings supporting psychosocial stress and poor nutrition as risk factors, there are suggestive data for several environmental chemicals. Independent studies have linked childhood exposure to lead (Pb) with risk of schizophrenia, anxiety and depressive symptoms in adolescence, and impairment in executive function, which is a shared feature of multiple psychiatric conditions. Exposure to a commonly used class of pesticides, organophosphate compounds, has been associated with symptoms seen in major depression, anxiety, and obsessive-compulsive disorders. Recent studies have linked gestational exposure to endocrine disrupting chemicals with higher anxiety, hyperactivity and depression scores in children.

Data obtained in model systems bolster the idea that environmental chemicals may be risk factors for psychiatric disorders. For example, multiple studies in rodents demonstrate that exposure to certain pesticides or to one or more chemicals found in air pollution can cause brain and behavioral changes that are consistent with a depressive phenotype. Other studies demonstrate an interaction of Pb with gene expression and function of several neurotransmitter systems that have been implicated in schizophrenia. Collectively, results from humans and experimental systems support the premise that multiple known neurotoxicants interact with several biologic pathways and processes (e.g., gene regulation, synaptic plasticity) that have been implicated by genetic studies of psychiatric disorders.

While few studies have examined the joint effects of genes and environment on psychiatric outcomes, a rapidly developing area of research has focused on epigenetic factors, such as DNA methylation, histone modification and non-coding RNA. A variety of environmental insults, including maternal stress and nutrition, heavy metals, pesticides, air pollution, and endocrine active compounds, have been linked to epigenetic alterations. Studies are beginning to explore how epigenomic changes in response to environmental chemical exposures may mediate environmental risk effects on psychiatric health outcomes.

Despite the progress cited above, additional attention is needed to accelerate the pace of research aimed at identifying environmental contributors to psychiatric disorders. A 2017 NIEHS-supported workshop brought together experts in psychiatry, fundamental neuroscience, human genetics, immunology, and environmental health sciences to identify gaps and opportunities for research in this emerging area. https://www.niehs.nih.gov/news/events/pastmtg/2017/biological-mechanisms/index.cfm Key gaps that emerged from this workshop include: few sufficiently-powered human studies with both exposure and clinical measures that can assess exposure-disorder associations and/or uncover gene-environment interactions; sparse data addressing if/how specific exposures affect cellular, molecular or circuit-level alterations associated with psychiatric disorders; uncertainties around mechanisms outside the brain (e.g., microbiome) and their role in mediating exposure-psychiatric disorder associations; and limited consideration among neurotoxicologists of dimensional approaches to behavioral measures (e.g., NIMH's Research Domain Criteria (RDoC) initiative; see http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml for more information).

Research Objectives and Scope

The purpose of this FOA is to stimulate research that builds on suggestive data linking exposures and psychiatric outcomes and increase our understanding of the biology underlying these relationships. The R21 grant mechanism used under this FOA is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. Therefore, investigations that further advance our understanding of psychiatric conditions where there is less evidence of an environmental exposure link are strongly encouraged.

Psychiatric outcomes of interest

Investigators should focus on psychiatric disorder(s) that typically emerge in late childhood, adolescence or early adulthood. When possible, applicants are encouraged to consider co-occurring psychiatric disorders/traits and potential shared etiologies. Investigators are also urged to transcend strict diagnostic boundaries to consider dimensional aspects of psychopathology that are observed in the general population and that may be associated with environmental exposures. For example, in addition to human studies that focus on clinically-diagnosed cases, those that examine continuous population traits relevant to psychiatric disorders and their association with environmental exposures are encouraged.

Assessment of psychiatric outcomes/phenotypes in humans or model systems

This FOA is open to projects using human/clinical populations, mechanistic laboratory-based models and/or interdisciplinary research approaches. New collaborations between psychiatric researchers and environmental health scientists are strongly encouraged. Applicants proposing human studies should provide a compelling rationale for the planned methods for assessing psychiatric disorders/traits including issues of validity and reliability. Investigators are encouraged to leverage existing data from human study populations with well-characterized environmental exposures and/or clinical diagnoses or symptoms. Applications proposing mechanistic studies in whole organism model systems should provide strong justification for the model and the phenotypes to be assessed (e.g., deficits in pre-pulse inhibition of the startle reflex response; impairments in executive function) and their relationship to the targeted psychiatric disorder(s)/trait(s). Use of in vitro and ex vivo cellular/molecular models (e.g., patient stem cell-derived neurons), with accompanying rationale for their relevance to psychiatric disorders/traits, are also welcomed.

Research approaches to link biology, exposure and psychiatric outcomes

All projects should go beyond clinical and behavioral assessments to incorporate one or more non-behavioral biologic measures that are directly relevant to the hypothesized relationship between the exposure(s) and psychiatric outcome(s) under study. Applicants should provide a strong justification for the biologic measure(s) proposed for study. Biologic measures may include, but are not limited to, genomic, metagenomic, transcriptomic, proteomic, metabolic and small molecule biomarkers of cellular processes using biospecimens from brain, blood or other relevant surrogate tissues. Measures of brain structure and/or function derived from in vivo/ex vivo approaches and/or postmortem assessments are also welcomed. Applicants are encouraged to capitalize on modern tools and approaches (e.g., chemogenetics and optogenetics, functional and structural brain imaging, population-based rodent models, exposomics) in their studies.

All studies, including exploratory R21 projects, that examine novel associations between exposure(s) and psychiatric outcomes without inclusion of a non-behavioral measure of biologic response would not be high priority for this FOA.

Environmental exposures of interest

The proposed project must fall within the NIEHS mission. Environmental agents which are considered of primary interest for NIEHS include: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Investigators who propose studies with a primary focus on NIEHS mission relevant exposures are encouraged to consider inclusion of other relevant environmental exposures (e.g., nutrition) in order to assess their role(s) as cofactors/modifiers of the risk or protection associated with the primary exposure(s). Applications that propose laboratory-based studies using only model compounds (i.e., those without potential for human exposure) must provide a clear, reasonable and specific description as to how research on the model compound will lead to a better understanding of the mechanisms involved in responses to specific environmental agents which are included in the mission responsibility of the NIEHS.

Specific Areas of Research Interest

Topics that are appropriate for this FOA include, but are not limited to, the following:

• Alterations in level or pattern of peripheral biomarkers (e.g., cortisol, cytokines) and their role in mediating the relationship between environmental exposures and psychiatric disorders/traits
• Neural circuitry underlying toxicant-induced changes in behavioral phenotypes relevant to psychiatric disorders/traits
• Relationship(s) between environmental exposures and synaptic processes (e.g., synaptic integrity, synaptic plasticity and/or synaptic transmission) that are implicated in psychiatric disorders/traits
• Epigenetic and epigenomic alterations (e.g., histone modifications, changes in DNA methylation, non-coding RNA regulation) caused by environmental exposures and their role in mediating the association of those exposures with psychiatric disorders/traits
• Impact of environmental exposures on gut microbiome and consequences for risk of psychiatric disorders/traits
• Development and/or application of screening tools to identify and investigate, in human populations, candidate exposures that interact with biological processes implicated in psychiatric disorders/traits
• Neurobiological changes underlying how environmental chemical exposures combine with other environmental factors (e.g., microbial pathogens such as viruses, diet and nutrition, psychosocial stress, substance use, physical activity levels) to protect or increase risk for psychiatric disorders/symptoms.
• Use of genetically engineered models (e.g., population-based rodent models) to identify susceptibility to exposure-related psychiatric phenotypes
• Application of functional genomics and/or novel statistical approaches to identify and validate gene-environment interactions using existing data from psychiatric studies
• Role of non-neuronal cell populations, which make up close to 90% of the cells in the brain, in the effects of environmental toxicants on psychiatric disorders/traits.

Applicants are strongly encouraged to contact the listed NIEHS Scientific/Research staff prior to submission to ensure their project is appropriate for this FOA.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

• 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

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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. 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.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications  

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Research Strategy should also include the following elements:

Approach:

Methods for assessing psychiatric disorders/traits

• For epidemiologic/clinical studies, describe the methods for assessing psychiatric diagnoses and their validity and reliability

• For human studies that do not entail clinically-diagnosed cases, provide a rationale for the methods for measuring trait(s) under investigation and their relevance to psychiatric conditions

• For studies in whole organism experimental systems, cellular and molecular models, provide a rationale for the phenotypes that will be assessed and their relationship to the psychiatric disorder/trait in humans

Non-behavioral biologic measures

• Identify and provide a justification for the non-behavioral biologic measure(s) that will be used to explore the relationship between the exposure(s) and psychiatric outcome(s) under study.

The following modifications also apply:

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

Significance  

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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 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?

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? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

Does the published literature support the appropriateness of the proposed non-behavioral biological measure(s) for probing mechanism(s) underlying the exposure-psychiatric outcome relationship? For human studies, are the methods for measuring psychiatric outcome(s) of interest valid and reliable? For non-human studies in cellular, molecular and whole organism models, what is the strength of evidence relating the proposed models and phenotypes to psychiatric disorders/traits in humans?

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 individuals of all ages (including children and older adults), 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?

Protections for Human Subjects  

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals  

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

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  

Not Applicable.

Revisions  

Not Applicable.

Applications from Foreign Organizations  

Not Applicable.

Select Agent Research  

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

Resource Sharing Plans  

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

Authentication of Key Biological and/or Chemical Resources:  

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.

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

• 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.

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

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

3. Reporting

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Jonathan A. Hollander, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3269
Email: [email protected]

Kimberly A. Gray, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3262
Email: [email protected]

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

Robbie D. Majors
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3284
Email: [email protected]

Section VIII. Other Information