Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative ( through the NIH Office of the NIH Director, Office of Strategic Coordination ( This FOA will be administered by the National Institute of Mental Health (NIMH) on behalf of NIH.

Funding Opportunity Title

Development and Application of Systems Approaches for Analyzing the Impact of Genomic Variation on Tissue Transcriptomes (R01)

Activity Code

R01 Research Project Grant

Announcement Type


Related Notices

  • November 16, 2012 - See Companion RFA-RM-12-009.
  • October 10, 2012 - See Notice NOT-RM-13-001. Additional Information, This Notice serves to clarify and update information.

Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity


Number of Applications

See Section III. 3. Additional Information on Eligibility.

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


Funding Opportunity Purpose

This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund, invites applications for R01 awards for statistical analysis of Genotype-Tissue Expression (GTEx) data. The goal of the GTEx program is to develop a data and sample resource to study the relationship between genetic variation and gene expression across multiple human reference tissues. By 2016 the GTEx program is expected to include genetic variation information from approximately 900 post-mortem donors and gene expression measurements from over 20,000 tissues. GTEx will represent a large, rich, and unique resource. This FOA is to develop and apply statistical methods and systems approaches to make maximal use of this data.

The primary interest driving the GTEx project is identification of genetic variation and its effects on the tissue transcriptome. Genetic variation can be based on SNP genotyping as well as copy number variants, small insertions/deletions, or epigenetic modifications. Examples of interest in this FOA are cis- and trans-acting variants in determining expression quantitative trait loci (eQTLs), tissue specific transcripts, identifying common transcripts in tissue clusters, and identifying allele-specific bias. In addition, novel approaches to examine other types of transcriptome effects are encouraged. Statistical methods based on single gene, regional chromosome architecture, gene-gene interactions, gene-networks, and broader systems approaches are also encouraged.

Key Dates
Posted Date

August 7, 2012

Open Date (Earliest Submission Date)

October 19, 2012

Letter of Intent Due Date

October, 19, 2012

Application Due Date(s)

November 21, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

August 1, 2013

Expiration Date

November 22, 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


Genetic studies of common and rare variants have shown great promise in identifying loci associated with common human diseases, such as heart disease, cancer, diabetes, and psychiatric conditions (for GWAS summary; See: Many of the single nucleotide polymorphisms (SNPs) associated with disease have small effect and are responsible for only a small portion of disease risk. These small effects may reflect subtle differences in the regulation of gene transcriptional activity. Furthermore, recognizing which gene(s) may be affected by the SNP is confounded by the potential for cis- or trans- acting effects over large distances. Thus, it is difficult to discern which gene(s) underlie the association signal and what the mechanism is.

The identification of genes whose expression is correlated with specific genetic variants (known as expression quantitative trait loci, or eQTLs) can serve as a tool to functionally characterize a disease-associated SNP and point to the underlying biological pathways. It has been shown that levels of gene expression, when treated as quantitative traits, are heritable in a variety of organisms. Based on genotype data in combination with transcriptome data from single tissues, such as liver, brain, adipose tissue, and lymphoblast cell lines, eQTLs may be more common than previously recognized. In recent studies, 5% - 10% of genes have cis-eQTLs, defined as correlations of a sequence variant within an arbitrary distance, typically 1,000 kilobases, of a gene, and cluster upstream of the transcribed region. Identification of cis-eQTLs contributes to our understanding of the impact genetic variation has on gene expression.

Human eQTL studies have thus far been limited primarily to cis- effects in a small number of tissues analyzed individually. To identify trans-eQTLs, meaning those in which the correlated SNP maps far from the gene, or even on a different chromosome than the gene it is regulating, much larger sample sizes are required. This is due to the need to adjust for the large number of statistical tests involved in searching for correlation between every transcript and a very large number of genetic variants.

SNPs are not the only type of variant that may exhibit cis- and trans- effects on eQTLs. Also of interest are copy number variants and smaller insertions/deletions that can exert distal effects on genes. These may have large regional effects on chromosome architecture as well as possible direct involvement with enhancer elements.

Analyses thus far have involved primarily single tissues from different subjects. The opportunity to study multiple tissues from the same individual has been limited; thus it is unclear the extent to which eQTLs identified in one tissue will also be relevant in others. Understanding the degree to which genetic influences on gene regulation may be tissue specific, with regard to overall expression levels, alternative transcript splicing, or allele bias, will require having genotype and transcriptome data for a wide range of tissues from the same individual. Similarly, to understand what is a significant difference in transcript abundance, it is important to have a measure of population variance by analyzing data for the same tissue from different individuals. The Genotype-Tissue Expression project (GTEx;, described below, provides such data sets.

The GTEx project is an NIH Common Fund initiative that aims to provide the scientific community a resource with which to study human gene expression and regulation and its relationship to genetic variation across multiple human tissues. The pilot project in 2010-2012 demonstrated the ability to establish a rapid autopsy enrollment system to collect high-quality tissues in a post-mortem setting. By 2016, the resource is expected to enroll a total of approximately 900 post-mortem donors, with approximately 30 tissues collected from each donor.

During the GTEx pilot, approximately 1,000 tissue specimens were measured with both a gene expression array (Affymetrix GeneChip Human Exon 1.0 ST) and by RNA-Seq (Illumina Hi-Seq 2000), but going forward only RNA-Seq, to a depth of >50,000,000 reads using a paired-end protocol, is planned. It is anticipated that more than 20,000 tissues will undergo gene expression measurements. A DNA sample from blood will be analyzed for genetic variation using the Illumina Omni 5M and the human exome array chips. Resulting genetic variation and gene expression measurements will be made available on a periodic basis through NCBI’s database of Genotypes and Phenotypes, dbGaP ( and eQTL results and other open access data will be available through a GTEx Data Portal ( Residual RNA, DNA, cDNA, PAXgene-fixed-paraffin-embedded samples, and PAXgene-fixed frozen tissue samples will be stored and made available to the scientific community. It is anticipated that additional molecular phenotypes will be measured on GTEx samples and integrated with gene expression data. Such molecular datasets may include measures of epigenetic marks and chromosome architecture possibly available in 2015 and 2016.

Research Objectives/Specific Research Areas

This FOA seeks grant applications that propose to develop advanced systems and innovative statistical approaches to analyze the forthcoming complex data sets, to assess the influence of genetic variation on the transcriptome, and assess transcriptome regulation. Applicants are expected to take advantage of the availability of the SNP and tissue specific gene expression data (both array based- and next-generation sequencing based RNA expression data) from multiple tissues generated by the GTEx project and available through dbGaP. However, incorporating additional data sets from the broader research community is encouraged and could serve to strengthen the power of the study and validate statistical approaches. Similarly, mapping identified eQTLs to external GWAS datasets from disease studies could provide some functional significance to GWAS SNPs associated with eQTLS. Examples of research areas that applicants may work on include the following (note this is not an all-inclusive list, and applicants are encouraged to address more than one area):

All other investigators funded by GTEx including: Biospecimen Source Sites, a Comprehensive Data Resource, a Comprehensive Biospecimen Resource, and a Pathology Resource Center managed by caHUB (; a Laboratory, Data Analysis, and Coordinating Center (LDACC); and a Brain Bank; as well as NIH Project Officers/Program Directors, form the "GTEx Consortium". The Consortium holds periodic teleconferences as well as two 1.5-day in-person meetings per year (usually in the Washington, DC area). Investigators funded under this FOA are expected to participate and abide by Consortium policies, including policies on publications and acknowledgments. The grantees from this FOA, along with the LDACC, and Program staff members will form a GTEx Statistical Analysis Working Group and are encouraged to collaborate, participate in data quality control efforts, and contribute results of their analyses for integration with other GTEx data.

Section II. Award Information
Funding Instrument


Application Types Allowed


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 NIH intends to commit approximately $3,300,000 total cost in FY 2013 to fund up to 8 awards.

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 applications submitted in response to this FOA may not exceed 3 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



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

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:

Patrick Bender, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 7200, MSC 9643
Bethesda, MD 20892-9643
Telephone: 301-443-6653

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

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

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:


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, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PD(s)/PI(s) in accord with the requirements stated in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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.


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? Does the proposed work have the potential to provide new insights into the mechanisms of gene regulation that contribute to differences in tissue phenotype and variation in phenotype based on genetic variation in an epidemiologic population sampling? Is consideration provided of the biological relevance of discovered variation and possible role in the disease phenotype?


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?


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? Is the proposed statistical approach(s) innovative, with either a sound theoretical basis or sufficient preliminary data to indicate success?


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? Is the approach comprehensive? Does the scientific approach build on the unique aspects of the GTEx datasets? Are both tissue-specific variation as well as inter-individual variation of the same tissue considered?

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?


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.


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.


Not Applicable.


Not Applicable.


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). Investigators responding to this FOA should include a plan for sharing research resources, agreeing to share their data with a Program-designated bioinformatics site that may consist of a GTEx Data Portal and/or dbGaP

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at 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 Customer Support (Questions regarding registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936

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

Scientific/Research Contact(s)

Susan Koester, Ph.D.
Division of Neuroscience and Basic Behavioral Science
6001 Executive Blvd. Room 7205
Bethesda, MD 20892
Fax: 301-443-1731

Peer Review Contact(s)

Richard Panniers, Ph.D.
Center for Scientific Review
Room 2212, MSC 7890
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-1741
Fax: 301-480-2067

Financial/Grants Management Contact(s)

Rebecca Claycamp
Grants Management Officer
Division of Extramural Activities
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811

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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