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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 Mental Health (NIMH)

Funding Opportunity Title

New Tools to Study Astrocyte Heterogeneity, Development and Function in Brain Regions Relevant to Mental Illness (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-13-010

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242

FOA Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH), National Institutes of Health, encourages research grant applications that propose the development or adaptation of cutting edge technologies for astrocyte research, discovery-based research on astrocyte diversity, development and/or function in the brain, and the application of these to the study of basic brain processes or pathophysiology relevant to mental illnesses. The primary objective of this FOA is to address barriers to astrocyte research that are due to the scarcity of tools and datasets to target and identify astrocytes rigorously. Applications should aim to transform the field of astrocyte research by generating resources that will be widely used throughout the neuroscience community. Research supported by this initiative will (i) provide new tools for manipulating and identifying astrocytes based on their heterogeneity, developmental stage or functional state; (ii) identify novel phenomic signatures and combinatorial regulatory mechanisms of astrocyte development/function that account for astrocyte diversity; (iii) characterize mechanisms by which astrocytes regulate neural circuits serving cognition, emotion and social function or contribute to abnormal neural function relevant to psychopathology.

Key Dates
Posted Date

November 21, 2011

Open Date (Earliest Submission Date)

February 9, 2012

Letter of Intent Due Date

February 9, 2012

Application Due Date(s)

March 9, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June 2012

Advisory Council Review

September 2012

Earliest Start Date(s)

December 2012

Expiration Date

March 10, 2012

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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH), National Institutes of Health, encourages research grant applications that propose the development or adaptation of cutting edge technologies for astrocyte research, discovery-based research on astrocyte diversity, development and/or function in the brain, and the application of these to the study of basic brain processes or pathophysiology relevant to mental illnesses. The primary objective of this FOA is to address barriers to astrocyte research that are due to the scarcity of tools and datasets to target and identify astrocytes rigorously. Applications should aim to transform the field of astrocyte research by generating resources that will be widely used throughout the neuroscience community. Research supported by this initiative will (i) provide new tools for manipulating and identifying astrocytes based on their heterogeneity, developmental stage or functional state; (ii) identify novel phenomic signatures and combinatorial regulatory mechanisms of astrocyte development/function that account for astrocyte diversity; (iii) characterize mechanisms by which astrocytes regulate neural circuits serving cognition, emotion and social function or contribute to abnormal neural function relevant to psychopathology.

Background

The NIMH Strategic Plan defines four overarching objectives designed to carry out our mission of transforming the understanding and treatment of mental illnesses through basic and clinical research. To accelerate progress toward this goal, NIMH is targeting a gap area in basic research on astrocyte function in the brain. Astrocytes make up a significant proportion of the cells in the brain. In addition to well-characterized roles for astrocytes in regulating brain metabolism, there is now an increasing body of evidence that astrocytes are dynamic regulators of synaptogenesis, synaptic function and network activity. This is conceptualized in the tripartite synapse model, where pre-synaptic and post-synaptic domains of neurons are surrounded and regulated by astrocyte processes. Astrogenesis occurs relatively late in development after most neurogenesis has completed; there may be sensitive periods in astrocyte maturation, tripartite synaptic formation and plasticity that correlate with the distinct trajectories of autism spectrum disorders, bipolar disorder, schizophrenia and other mental illnesses (see http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/neurodevelopment_workgroup_report.pdf). There is evidence linking astrocytes to several major mental illnesses. An emerging literature suggests astrocyte involvement in schizophrenia, including aberrations in extracellular matrix proteins, perineuronal nets and serine metabolic pathways. Astrocyte dysfunction may be directly involved in major depression, indicated by post-mortem studies showing glial cell count alterations in multiple brain regions. Recent evidence suggests a relationship to suicide, where transcriptional down-regulation of connexins occurs in astrocytes. Additionally, astrocytes regulate synaptogenesis via pathways that are also implicated in autism. While these results are intriguing, much work remains in order to determine the role of astrocyte function in the pathophysiology of mental illnesses.

Despite progress and potential significance, cellular, developmental and systems-level studies of astrocytes still lag far behind those of neurons. For example, extensive research has led to the identification of multiple inhibitory neuron subtypes, generated by distinct combinatorial transcription factor codes and having distinct developmental trajectories, connectivity and electrophysiological characteristics. In contrast, a corresponding gap in knowledge about astrocytes has been due in large part to the scarcity of tools to identify and target astrocytes rigorously. Astrocyte research has traditionally relied on a small number of markers such as glial fibrillary acidic protein (GFAP) and S100beta, which are increasingly viewed as insufficiently selective for or inclusive of the normal astrocyte population. Additionally, despite evidence showing pronounced region- and layer-specific morphological heterogeneity as well as region-specific actions of astrocytes on neuronal functions, currently available tools have had limited utility for examining functional diversity among astrocytes.

A recent convergence of new astrocyte markers and genetic tools to study astrocyte function may provide traction to address this gap, and ultimately to yield mechanisms or predictive measures of astrocyte function relevant to mental illness. Improved methods to purify astrocytes led to the identification of aldehyde dehydrogenase 1 L1 (Aldh1L1) as perhaps the most inclusive marker of astrocytes yet identified. An alternative approach that paired genetic tagging of cells with translational profiling has identified unique expression profiles between astrocytes in different regions of the brain. A third approach, analyzing transcription factors selectively expressed in germinal zones during periods of astrogenesis, identified Klf15 as sufficient for astrocyte generation. These findings may break a bottleneck and catalyze further discovery and characterization of factors underlying astrocyte diversity, development and function in the brain. Progress has also occurred by adapting previously developed methodologies for use on astrocytes. For example, expression profiling of Olig2 mutant mice led to the characterization of novel reporters of, and combinatorial homeodomain transcription factors controlling, distinct astrocyte subtypes in the ventral spinal cord, in a manner similar to that of neurons. The recent use of an optogenetic tool for controlling astrocyte function showed that astrocytes are a key component of respiratory chemoreception and rapidly modulate brainstem neurons responsible for breathing rate, indicating a direct role for brain astrocytes in mediating physiological reflexes. These results show that many technologies such as genetic screens, fate mapping, conditional mutagenesis, in vivo imaging and optogenetics can readily be adapted to detailed mechanistic studies of astrocytes.

Objectives

This FOA encourages research grant applications that propose the development or adaptation of cutting edge technologies for astrocyte research, discovery-based research on astrocyte diversity, development and/or function in the brain, and the application of these to the study of basic brain processes or pathophysiology relevant to mental illnesses. The primary objective of this FOA is to address barriers to astrocyte research that are due to the scarcity of tools or datasets to target and identify astrocytes rigorously. Applications should aim to transform the field of astrocyte research in part by generating foundational resources (e.g., tools, model organisms, methods, datasets, knowledge base) that will be widely used throughout the basic and translational neuroscience community. The Research Strategy should include indicators of progress (i.e., milestones) and how these will be used to inform the next phase of tool, model organism, method, dataset and/or knowledge base development. Milestones should be included as part of each annual progress report and the final report for the grant, as described in Section IV. Applications that propose to generate these new resources, including discovery-based datasets, must include a detailed plan for resource and/or data sharing as described in Section IV. All projects must have relevance to brain function but can encompass astrocyte studies during prenatal, early postnatal, adolescent development and/or adulthood. Applicants may also submit integrative and interdisciplinary applications crossing multiple (e.g., molecular, cellular, circuit, behavioral) levels of analysis and those involving humans, model vertebrates/invertebrates or in vitro preparations. Applications are not required to be hypothesis-driven; discovery-based or high-risk applications are strongly encouraged.

Responsive applications must address at least two of the following three topics:

1. Develop or adapt new tools for reporting or manipulating astrocyte development, subtype identity or function. Examples include, but are not limited to:

2. Define the molecular basis of functional heterogeneity across astrocyte subtypes in the brain with an emphasis on discovery-based approaches. Examples include, but are not limited to:

3. Assaying astrocyte development or function in brain regions/circuitry/domains of function relevant to mental illnesses in normal or pathophysiological conditions. Examples include, but are not limited to:

This FOA is not intended to support applications to study glia other than astrocytes (e.g., oligodendrocyte or microglial lineages), stem cells with astrocyte-like phenotypes (e.g., radial glia, subventricular zone type B cells), or biological processes with primary relevance to diseases outside of the NIMH mission (e.g., reactive gliosis after or astrocyte response to stroke, seizure, neurodegeneration, traumatic injury or environmental pollutants). Applications that rely mainly on traditional methodologies to manipulate or assay astrocytes will be considered non-responsive. Such non-responsive applications will be administratively withdrawn before review. Applicants are strongly encouraged to consult with the appropriate program official, listed in Section VII, to discuss the relevance of their proposed work to the NIMH mission and the FOA as well as to ensure that proposed studies do not duplicate projects currently supported.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
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 NIMH intends to commit approximately $4,000,000 total costs in FY 2013 to fund 8 or more awards in response to this FOA.

Award Budget

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

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five 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.

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:

David M. Panchision, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 451-5615
Email: [email protected]

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:

Progress Indicators

The Research Strategy should include indicators of progress (i.e., milestones), which should be tailored to the unique scope of each application and written concretely enough to evaluate whether a deliverable has been achieved (e.g., a crucial step in tool making, validation or testing in a model system; dataset acquisition, analysis, annotation or sharing; proof or disproof of a specific hypothesis). This should be included within the page limit of the Research Strategy. If funded, investigators should describe progress toward milestones in each annual progress report and as part of the final report of the grant.

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. Since a central goal of this initiative is to generate transformative resources that will be widely used throughout the neuroscience community, applications that propose to generate such resources (e.g., new tools, reagents, model organisms, methods or discovery-based datasets) are expected to include a detailed plan for sharing these resources, consistent with achieving the goals of this program.

All sharing plans for resources other than data should include the following key elements:

Data sharing plans are encouraged to utilize national or international bioinformatics resources if available. In particular, applications that propose autism-related research involving human subjects or biomaterials are encouraged to coordinate with the National Database for Autism Research (NDAR) (http://ndar.nih.gov/ndarreports/faces/reports/reports.iface). All data sharing plans should include the following key elements:

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(s)/PI(s) 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 and responsiveness by the NIMH, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) 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-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? How will the project address barriers to astrocyte research that are due to the scarcity of tools or datasets to identify and target astrocytes rigorously? How will the study lead to a substantial improvement in the ability of future research to account for astrocyte heterogeneity, development or function in brain processes, or a fundamental shift in understanding how these processes relate to mental illnesses? Does the application transform the field of astrocyte research by generating foundational resources that will be widely used throughout the basic and translational neuroscience community?

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? For studies using high risk or discovery-based approaches, do the investigators and collaborators have a track record of success, or appropriate training, in relevant topic areas or methodologies?

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? If developing new tools or adapting cutting edge techniques originally developed for other purposes, how do these provide a major change in practice from previous methods for studying astrocytes? If addressing astrocyte heterogeneity, how are innovative concepts or approaches used to identify phenotypic subtypes, developmental stages or functional states underlying this heterogeneity? If addressing astrocyte processes in brain regions relevant to mental illnesses, how does the study provide conceptually or technically novel ways of understanding astrocyte processes in normal or pathophysiological states, or how does the study synthesize approaches such as using multiple levels of analysis (e.g., molecular, cellular, circuit and behavioral) to enhance relevance to mental processes or illnesses?

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?

If developing new tools, how will the tools be made sufficiently selective or appropriate for the intended use in astrocytes? If addressing astrocyte heterogeneity, how will the methodologies lead to a rigorous distinction between diverse astrocyte regional subtypes, developmental stages and/or functional states? If addressing astrocyte processes in brain regions relevant to mental illnesses, how will the design permit the generation of an appropriate discovery-based dataset or a rigorous determination of the role of astrocytes as it relates to development, function, plasticity or pathophysiology? Are the proposed progress indicators (milestones) adequate for assessing the scientific accomplishments, both yearly and overall, of the project?

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

Not Applicable.

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/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). Since a central goal of this initiative is to generate transformative resources that will be widely used throughout the neuroscience community, applications that propose to generate such resources (e.g., new tools, reagents, model organisms, methods or discovery-based datasets) are expected to include a detailed plan for sharing these resources, consistent with achieving the goals of this program. Reviewers may comment on whether relevant sharing plans adequately address key elements described in the Section IV instructions of this FOA. .

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 NIMH, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Scientific/Research Contact(s)

David M. Panchision, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 451-5615
Email: [email protected]

Peer Review Contact(s)

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
Email: [email protected]

Financial/Grants Management Contact(s)

Victoria Carper, MPA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
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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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