Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Environmental Contributors to Autism Spectrum Disorders (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-203

Companion Funding Opportunity

PAR-14-202, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113, 93.865, 93.242

Funding Opportunity Purpose

The purpose of this FOA is to stimulate and foster research to (1) identify environmental contributors to risk and expression of autism spectrum disorders (ASD) and (2) understand how environmental factors impact the underlying biologic processes implicated in ASD. A range of approaches are being encouraged by this FOA, from basic mechanistic studies using in vitro and in vivo model systems to studies that add new data collection activities and/or make use of extant data or biospecimens in existing human studies. Studies that address hypotheses related to the joint contribution of genes and environment are of particular interest. It is anticipated that knowledge gained from the research supported by this FOA will be used to inform public health prevention and intervention strategies

Key Dates
Posted Date
Open Date (Earliest Submission Date)

July 26, 2014

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

August 26, 2014; August 26, 2015; August 26, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January 2015; January 2016; January 2017

Advisory Council Review

May 2015; May 2016; May 2017

Earliest Start Date

July 1, 2015; July 1, 2016; July 1, 2017

Expiration Date

August 27, 2016

Due Dates for E.O. 12372

Not Applicable

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.

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


Background

Autistic disorder and related conditions, known collectively as autism spectrum disorders (ASD), are characterized by significant impairments in reciprocal social communication and the presence of repetitive and/or restricted behaviors and interests. The symptoms of ASD emerge in the first three years of life. Some individuals are mildly impaired by their symptoms, while others are severely disabled. In addition to the core behavioral features of autism, many individuals are affected by other medical conditions, including epilepsy and intellectual disability. In most cases, ASD is a life-long condition and represents an enormous collective burden for affected individuals and families. Once thought to be rare, the most recent surveillance data show that ASD affects as many as 1 in 68 children within the United States. The prevalence of ASD has risen dramatically over the past twenty years, and recent data indicate that the upward trend continues. Part of this increase reflects changes in diagnostic criteria, improved identification linked to increased awareness by families, educators and clinicians and the wider availability of services for affected individuals. These factors alone are unlikely to fully explain the dramatic increase in prevalence, however, and a portion may reflect changes in the patterns and/or intensity of environmental exposures, acting in concert with genetic susceptibility.

Recent progress in understanding autism etiology

Increased attention and funding for ASD research in the past decade have spurred considerable progress in identifying etiologic risk factors and the underlying pathobiology. The phenotypic heterogeneity of ASD is consistent with the idea that the autism spectrum encompasses a range of disorders, with many different causes. The pattern of brain abnormalities observed in individuals with ASD, together with promising results of biomarker research in infants, suggest that disruption of the biologic process(es) that ultimately give rise to ASD symptoms begins very early in life.

Multiple lines of evidence support a strong genomic basis for ASD, including results from twin and family studies and the known association with single gene disorders and chromosomal abnormalities. Recent findings point to an unexpected role for rare structural genomic variations, ranging from de novo insertions and deletions to single nucleotide variation. To date, a very large number of rare structural variants have been linked to ASD, with different genes, or sets of genes affected in different individuals with ASD. Many ASD genes appear to converge on a few common biologic pathways, including those focused on synaptic maturation and maintenance. A role for epigenomics is suggested by the presence of ASD in individuals with disorders associated with epigenetic mutations (Fragile X syndrome) or that involve key epigenetic regulatory factors (Rett syndrome), parent of origin effects and/or linkage with imprinted chromosomal regions.

Recent efforts to identify environmental contributors to ASD and their interaction with genetic/genomic susceptibility have also begun to make progress. For example, results of several studies report an increased risk of ASD associated with exposure to traffic-related air pollution during gestation and early postnatal life. Other environmental factors with suggestive evidence for an association with ASD include maternal exposure to pesticides, infections, dietary folate and specific pharmaceuticals. An enhanced susceptibility to environmental exposures is suggested by the presence of abnormal immune responses, as well as metabolic and mitochondrial abnormalities observed in some individuals with ASD. Both maternal and paternal age at conception increase risk for ASD in the offspring, and this may reflect, in part, the accumulation of exposure-related genetic abnormalities in germ cells. Finally, there has been speculation that exposures affecting ASD risk act through epigenomic mechanisms. This is a plausible hypothesis given the demonstrated role of epigenomics in ASD-related conditions and the increasing data available to support the impact of environmental chemicals on epigenomic regulation of gene transcription.

Despite the progress cited above, additional attention is needed to accelerate the pace of research aimed at identifying environmental contributors to ASD. The published epidemiologic findings are intriguing, but most need independent replication and the neurobiology underlying reported associations is unclear. Very few mechanistic studies using in vitro approaches or model systems have been initiated. While many environmental exposures have known neurodevelopmental effects, and merit investigation as ASD risk factors, few have been studied in sufficient detail. Investigators have not exploited fully existing epidemiologic and clinical data and samples that could be used for the study of environmental contributors to ASD. For the most part, genetic and genomic studies are occurring in parallel with those on the environment, with little attention to a consideration of joint genetic and environmental contributors.

Purpose

The purpose of this FOA is to stimulate interest in pursuing hypotheses related to identification and mechanistic understanding of environmental contributors to risk and expression of autism spectrum disorders. The near-term expected outcomes are an increase in the number of investigators exploring environmental etiologies of ASD, expanded use of existing population and clinical ASD resources and application of new tools and approaches for mechanistic studies in model systems. The expected longer term outcome is an improved understanding of environmental causation of ASD leading to public health prevention and intervention strategies to reduce the disabilities associated with ASD.

Specific Areas of Research Interest

New collaborations between autism researchers and toxicologists are encouraged in pursuit of interdisciplinary research approaches. Human studies proposed under this FOA should capitalize on existing study infrastructure and samples rather than propose development of new cohorts.

Research questions and approaches meriting additional attention include but are not limited to those listed below.

Human studies in clinical and population samples are needed to:

Studies using in vitro, cellular and whole organism models are needed to:

Applications submitted to this FOA should have a primary focus on an environmental agent within the missions and priority areas of one of the participating NIH institutes, as detailed below. Applicants proposing to focus on environmental exposures that are not identified explicitly in the sections below are encouraged to contact Scientific/Research staff at the participating institutes to discuss whether specific exposures are within the mission interests and priorities.

NIEHS interests

NIEHS is interested in applications that have a focus on environmental exposures within its mission, especially when considered in the context of genetic susceptibility and gene-environment interaction, including exposure-related epigenetic modification of gene expression resulting in DNA methylation, histone modifications, or changes in ncRNA. Studies linking prenatal exposures within the NIEHS mission to autistic phenotypes with consideration to vulnerable windows during development are of particular interest.

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.  Applicants are strongly encouraged to contact NIEHS Scientific/Research staff prior to submission to determine if their project meets the interests of the NIEHS.

NICHD interests

NICHD is interested in applications that focus on environmental exposures that occurred prenatally during critical windows of fetal development and that impact early child development.  Examples of exposures include medications used during pregnancy, prenatal infections, maternal immune or inflammatory conditions, other medical conditions of the mother, specific nutrient or dietary exposures, and psychosocial factors.  Specifically, NICHD is interested in studies focusing on prenatal exposures that alter the genetic or epigenetic profile and predispose to autism susceptibility; factors that alter the maternal or offspring microbiome and affect infant development; prenatal exposures to maternal disease, condition(s), or medication(s); and the presence of significant inflammation in utero and how it might be quantitatively related to altered cellular function and development in the offspring. NICHD is also interested in specific gene-environment interactions influenced by prenatal exposures. Applicants are strongly encouraged to contact NICHD Scientific/Research staff prior to submission to determine if their project meets the interests of the NICHD.

NIMH interests

NIMH is interested in research projects that seek to elucidate the role of genetic and epigenetic mechanisms modulated by environmental exposure(s) on gut microbiome in patients with ASD and control populations with the goal of identifying genetic pathways associated with ASD. Investigators are strongly encouraged to leverage existing longitudinal exposure data and detailed phenotypic assessments available on patients with ASD to evaluate the effect of environment on host gut microbiome and its role in autism.

NIMH is also interested in studies elucidating the relationship of environmental factors to genetic or epigenetic signatures that have been implicated in ASD, and in the identification and analysis of gene-environment interactions in the context of Genome-Wide Association Studies (GWAS) or other large scale genetic studies. Such analyses should leverage existing genetic and epigenomic data for characterization of phenotypes. Also of interest are projects that would utilize the National Database for Autism Research (NDAR) to develop methods to provide data on environmental exposures to the research community, without revealing the exact geospatial location of a research subject.

NIMH encourages the use of cutting edge approaches to understand how environmental exposures impact genomic, cell signaling, systems and circuit mechanisms regulating cognitive, affective, and social domains of function relevant to ASD, as well as the critical developmental processes underlying these mechanisms. Also encouraged are studies that seek to understand how environment perturbs normative neurobiological development of systems and circuits relevant to cognitive, affective, and social behavior using innovative approaches such as simultaneous high density electrophysiological recordings of multiple brain areas and optogenetic approaches. Computational modeling approaches to investigate how exposures alter complex rhythmic patterns of neuronal activity that underlie dynamic gating of information and how they are linked to relevant- functional alterations are also encouraged.

Applicants are strongly encouraged to contact NIMH Scientific/Research staff prior to submission to determine if their project meets the interests of NIMH.

Grantee Meetings:

In order to facilitate collaboration and information sharing amongst individuals funded under this FOA, the PD(s)/PI(s) will be expected to participate in annual grantee meetings. Other personnel associated with the project may also participate.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (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 limited to $400, 000 direct costs for each year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Patricia Greenwel, Ph.D.
Telephone: 301- 435-1169
Email: greenwelp@csr.nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

A kick-off meeting will be scheduled shortly after awards are made. The meeting will be held at or near NIEHS, in Research Triangle Park, NC. Yearly in person meetings are expected to take place over the project period. Funds for the PD(s)/PI(s) to travel to these yearly meetings should be included in the budget request.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 modification:

Sharing Human Data via the National Database for Autism Research: In order to advance the goal of widespread data sharing among ASD researchers, investigators funded under this FOA who are collecting data from humans are expected to share those data via the National Database for Autism Research (NDAR). Established by the NIH, NDAR is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDAR links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDAR. To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDAR web site provides two tools to help investigators develop appropriate strategies: 1) the NDAR Data Sharing Checklist - a list of critical steps in the data submission process, including informed consent language and GUID generation; and 2) the NDAR Data Submission Planning Cost and Effort Model - a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDAR and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see Data Sharing Regimen for more information). The NDAR Data Sharing Policy is available for review on the NDAR web site (http://ndar.nih.gov/ndarpublicweb/policies.go). NDAR staff will work with investigators to help them submit data types not yet defined in the NDAR Data Dictionary. For answers to frequently asked questions and how to contact NDAR, please see: http://ndar.nih.gov

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

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 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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the IC Referral Office by email at Haugen@niehs.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.



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 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/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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Cindy Lawler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4671
Email: lawler@niehs.nih.gov

Alice Kau, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-496-1383
Email:  kaua@mail.nih.gov

Lisa Gilotty, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-3825
Email:  gilottyl@mail.nih.gov

Peer Review Contact(s)

Patricia Greenwel, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1169
Email: greenwelp@csr.nih.gov.

Financial/Grants Management Contact(s)

Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-316-4638
Email:  boggsw@niehs.nih.gov

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone:  301-443-8811
Email:  tkees@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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