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

Center for Genomic Studies on Mental Disorders (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-MH-08-100

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-13-050

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.242

Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH) seeks Resource-Related Cooperative Agreement (U24) applications to continue, enhance, and enrich research resources in the NIMH Human Genetics Initiative for free and open sharing with the scientific community.  The long-term objective of data sharing and research resource enrichment under this FOA is to accelerate gene discovery in mental disorders.  It is expected that the Center will be comprised of a team of investigators with expertise in molecular biology, cell culture, computer and information sciences, statistical genetics and psychiatric genetics.  It is also expected that this effort will involve activities at multiple institutions that are strategically and functionally coordinated such that the Center will function as a single, national resource. A critical feature of the Center will be the banking of primary cultures of source cells for the derivation of induced pluripotent stem cells (iPSCs) and the banking of established iPSCs by investigators. Furthermore, the development and maintenance of a genomic cyberinfrastructure is required.  Such an infrastructure will represent the coordinated aggregate of software, hardware and other technologies, as well as the necessary staff expertise required to support current and future discoveries in the genetics of mental disorders. This cyberinfrastructure will integrate relevant and often disparate genetic and genomic resources to provide a useful, usable, and enabling framework for human genetic research and gene discovery in mental disorders that will be characterized by broad access.

Key Dates
Posted Date

May 30, 2012

Letter of Intent Due Date

July 1, 2012

Application Due Date(s)

August 1, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2012  

Advisory Council Review

January 2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

August 2, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

The identification of genetic and environmental contributions to disease and response to treatment is a major public health challenge. Several recent developments and technological advances in genetic sciences suggest that progress may be quite rapid. These include the sequence of the human genome, identification of large numbers of single nucleotide polymorphisms (SNPs), affordable high-throughput multiplexed systems for identifying genetic variation, and affordable sequencing approaches, that are applicable to the discovery of copy number variants, functional SNPs, indels, and epigenetic signatures. These new technological advances along with emerging methods to measure environmental exposures, offer promise in understanding the etiology of mental disorders.

Realization of the full potential of these tools and technologies for accelerating discoveries in human genetics will be achievable through free and open sharing of genetic material, phenotypic data and genetic analysis tools among researchers. For mental disorders and other genetically complex diseases in which gene effects are modest, sharing is often absolutely critical to achieve sample sizes that have adequate statistical power for gene mapping and mutation detection. Other specific scientific advantages of sharing research resources include facilitating the rapid replication of new findings, stimulating multidisciplinary translational research programs that include clinical and basic scientists, providing needed resources to promising young investigators, avoiding duplicative data collection efforts and laboratory work, and facilitating the rapid application of state-of-the-art genomic technologies and analytic methods to human genetic data sets. These advantages are expected to facilitate our understanding of pathophysiology, and accelerate the development of new therapeutic compounds and diagnostic tests.

In the late 1980's, NIMH launched a Human Genetics Initiative (http://www.nimhgenetics.org/) to characterize the genetic basis of vulnerability to schizophrenia, Alzheimer disease, and bipolar disorder. The main goal of this effort was to establish a national resource available to the scientific community aimed at accelerating gene discovery through the sharing of clinical information, DNA samples, and cell lines coordinated through an electronic database.  In 1997, a workgroup of the National Advisory Mental Health Council reviewed the NIMH genetics research portfolio and recommended that NIMH continue to fund large-scale data collection efforts and to maintain a repository of DNA and clinical data for sharing with the scientific community. The Workgroup also discussed future expansion of these efforts to include other mental disorders. At a joint meeting in September 2000, the National Advisory Councils of both NIMH and the National Institute of Neurological Disorders and Stroke recommended that data sharing for the genetic analysis of complex diseases supported by these Institutes continue to be strongly encouraged. Further developments accumulated in an initiative in 2011 to expand repository cell culture capacities to include primary source cells and induced pluripotent stem cells (iPSCs).

In order to continue to enhance and enrich research resources in the NIMH Human Genetics Initiative for free and open sharing with the scientific community, NIMH plans to fund one Center under this FOA. The long-term objective of data sharing and research resource enrichment under this FOA is to accelerate gene discovery in mental disorders that include Alzheimer disease, attention-deficit hyperactivity disorder, autism/related spectrum disorders, bipolar disorder/other related mood disorders, recurrent early-onset depression, eating disorders, obsessive-compulsive disorder/other anxiety disorders, panic disorder and schizophrenia/other psychotic disorders.

As this resource matures, high-throughput biological data sources hold the promise of revolutionizing molecular biology by providing critical information from genomic sequence, gene expression experiments in silico comparative genomic studies, and model cell culture systems directly relevant to mental disorders. Complexities arise, given that genomic information is scattered across hundreds of heterogeneous and autonomous information systems - each with their own interfaces and control languages - that represent information using inconsistent data models and formats. Computing grids and more sophisticated ontology-based tools to integrate, analyze and visualize genomic data will be critical for in silico gene discovery and elucidation of regulatory networks. A genomic cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources by the scientific community will be essential to improve research productivity and enable scientific breakthroughs not otherwise possible. 

Program Objectives

The intent of this FOA is to seek applications for and support one Center for Genomic Studies on Mental Disorders to serve as a national and international resource to the scientific community. The Center funded under this FOA can be directed by a Program Director/Principal Investigator (PD/PI) or multiple PDs/PIs with a designated contact PD/PI, and will receive guidance from NIMH program staff to assist with identification and implementation of appropriate strategies and priorities. It is expected that the Center will be comprised of an integrated team of investigators (within a single institution or across institutions) with expertise in molecular biology, technologies for primary and iPSC cultures, computer science and information technology, along with statistical and psychiatric genetics.  The successful applicant is expected to have experience in deriving iPSCs, although this is not a major component of the work scope. This effort may involve activities at multiple institutions that are strategically and functionally coordinated such that the Center will function as a single, national resource.

Given that genome mapping and sequencing projects push the frontiers of molecular biology, genetics and genomics toward information science, a critical feature of the Center will be the establishment of a genomic cyberinfrastructure that represents the coordinated aggregate of software, hardware and other technologies, as well as Center staff expertise required to support current and future discoveries in the genetics of mental disorders. This cyberinfrastructure will integrate relevant and often disparate genetic and genomic resources to provide a useful, usable, and enabling framework for human genetic research and gene discovery in mental disorders that will be characterized by broad access and “end-to-end” coordination.

It is expected that that the Center's staff have direct experience in providing to the scientific community research resources and services for genetic studies, as well as experience in establishing cyberinfrastructure for a mature scientific discipline. Specific areas of scientific expertise required by the Center include, but are not limited to, the following:

Research Topics

Specific functions and services to be performed by the Center for the scientific community may include, but are not limited to:

These services and research resources will be provided to the scientific community by the Center on a fee-for-service basis.  Fees charged will recover costs and service delivery costs.  Applications in response to this FOA should include detailed plans for the advisory, research and development, and other fee-for-service functions of the Center.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMH intends to commit approximately $9,000,000 in FY 2013 to fund one new cooperative agreement in response to this FOA.

Award Budget

An application may request up to $9,000,000 total cost per year.

Award Project Period

The total project period may not exceed 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

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 not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 Directors/Principal Investigators (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 least4-6 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 PHS398 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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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.  

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

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
6001 Executive Boulevard, Room 7190, MSC 9643
Bethesda, MD 20892-9643
Telephone:  301-443-6653
FAX:  301-402-4740
Email: patrick.bender@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

NIMH Referral Office
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-443-3367
FAX: 301-443-4720
Email: nimhreferral@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 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 PHS398 Application Guide.

NIH expects applicants who respond to this FOA to develop and propose detailed plans for data sharing. It is expected that data sharing plans minimally include all phenotypic and genotypic data. All data and biomaterials managed and produced by the Center are expected to be widely distributed to the national and international scientific community, consistent with achieving the goals of this program.

It is expected that the Center's data sharing plan will include the following elements:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  Standard Operating Procedures and ancillary materials are allowed in the appendix, but critical data and information should be placed in the Research Strategy. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Additional Budget Consideration

The Center funded through this FOA will have a Steering Committee to provide oversight (see below Cooperative Agreement Terms and Conditions of Award). The requested budget should include travel funds for approximately 4-5 steering committee members to attend a one day committee meeting on site once per year.

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 proposed Center 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 Center 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 Centert that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Centert address an important problem or a critical barrier to progress in the field? If the aims of the proposed Centert 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? If the aims of the application are achieved and research resources for genetics studies are freely shared with the scientific community and a genomic cyberinfrastructure established to integrate relevant and often disparate resources to provide a useful, usable, and enabling framework for genetic research and gene discovery, how will knowledge on the genetic basis of mental disorders be advanced?  What will be the effect of these research resources on other scientific activities that drive this field? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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 PD(s)/PI(s) have demonstrated experience in providing high-quality research resources and services for genetic studies on mental disorders to the scientific community? Is the PD(s)/PI(s)  highly committed to the principles of free and open sharing of research resources for genetic studies of mental disorders?

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? Does the proposed Center employ novel concepts, approaches, or methods for the production and sharing of research resources and for the development of genomic cyberinfrastructure? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 proposed Center 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 genomic cyberinfrastructure developed by the Center succeed in accelerating the discovery of genes producing vulnerability to mental disorders? Does the applicant utilize state-of-the-art methods to create an efficient cyberinfrastructure? Does the investigator utilize appropriate molecular biological techniques to assure a high rate of success (98% or greater) in establishing cell lines from both blood and biopsied sources?

Are appropriate procedures proposed and expertise documented in the preparation of primary cell lines, expansion of established iPSC lines, transformation of lymphocytes cells, and extraction of nucleic acids from cell culture and blood sources?  Are appropriate procedures proposed and expertise documented in performing quality control measures to assure cell line purity, genetic stability, and, where appropriate, reprogramming efficiency of cell lines? Are procedures proposed and expertise documented in the preparation of nucleic acids and quality control measures to assure purity, and competence as substrates in molecular biology assays? 

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? Does the proposed Center contain a description of the physical plant including appropriate and secure storage facilities assuring the integrity and viability of biological samples?  Are there fail safe procedures with automated alarming and notification systems along with appropriate emergency action and backup plans?      

Additional Review Criteria

As applicable for the Center 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 Center 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable. 

Additional Review Considerations

As applicable for the Center  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

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 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 and 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.l 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U24, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Applicants responsive to this FOA agree to:

The application should include a travel budget for 4-5 GSC members (excluding extramural program staff) to meet once per year.

The PD(s)/PI(s) will have the primary responsibility for the large scale receipt, processing, inventory, and distribution of biomaterials submitted by approved investigators as well as the integration of data sets incorporating phenotypic, diagnostic, and often genetic information in a user accessible bioinformatics platform.  Research endeavors may include new processing procedures, quality control parameters, biomaterial products, and an evolving cyber structure for integrating data.  The grantee agrees to accept the involvement of a Genomics Steering Committee (GSC) in the oversight of these endeavors. The grantees will coordinate and participate in at least two GSC meetings per year, one in person meeting and the other by teleconference.  The GSC will set research priorities and milestones, decide optimal research approaches and protocol designs, and contribute to the adjustment of research protocols or approaches as warranted.

The PD(s)/PI(s) will have specific reporting responsibilities including:

The awardees will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIH support, including the assigned cooperative agreement award number.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A.  The NIMH Project Scientist (or designated alternate in the event the Project Scientist is not available) will have substantial programmatic/scientific involvement that is above and beyond the normal stewardship role in awards, as described below:

B.  The Project Scientist for this award will be Patrick Bender, Ph.D., Genomics Research Branch/Division of Neuroscience and Basic Behavioral Science/NIMH/NIH. 

C.  The NIMH Program Officer has usual stewardship responsibility for monitoring the conduct and progress of the project.  The Program Officer carries primary responsibility for periodic review and approval of the study protocol in relation to stated recommendations regarding continuance of the project, receives all required reports and determines that satisfactory progress is being made, and attends the GSC meetings as a non-voting participant. The Program Officer will be Thomas Lehner, Ph.D., Chief, Genomics Research Branch/Division of Neuroscience and Basic Behavioral Science/NIMH/NIH.

Areas of Joint Responsibility include:

The Genomic Steering Committee (GSC) will serve as the governing board of the Center.  The GSC will be composed of the PD/PI, a minimum of four key outside scientists (advisors), the NIMH Project Scientist, and the NIMH Program Officer (as a non-voting member).  The four outside scientists will be selected by the PD/PI with agreement of the Program Officer. They will be selected for their broad scientific expertise and relevance to the goals of the Center.  Additional members may be added to the GSC by recommendation of the existing GSC members.  These additional GSC members can be NIH Intramural Scientists or NIH extramural program staff with recognized expertise.  Meetings of the GSC will be held at least two time per year with one meeting by teleconference and a yearly meeting in person.  Additional teleconferences of the GSC can be arranged by request of any GSC member. The GSC will provide governance through the review of progress, discussion and recommendations on new initiatives, discussion and recommendations on the design of research activities, and evaluations based on program milestones.  It is expected that decisions made or actions taken by the GSC will be by consensus, or majority vote when needed; the PD/PI, member scientists, and the NIMH Project Scientist each having one vote. The NIMH Program Officer will not have a vote.  Membership on the GSC becomes effective upon issuance of the Notice of Grant Award.

Outside consultants/experts may be asked to participate in GSC meetings and discussions as non-voting participants. Furthermore, the GSC may request the formation of an outside Scientific Advisory Panel (SAP) to provide advice to the GSC.  The size of the SAP is at the discretion of the GSC.  Appropriate meeting format will be decided by the GSC in discussion with the SAP.  Recommendations from the SAP will be conveyed to the GCS either through discussion or in writing through the Project Scientist.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIMH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will consist of the following: a designee of the awardees, chosen without NIMH staff input; one NIMH designee, and a third designee with expertise in the relevant area who is chosen by the first two. Failure to comply with the decision of the panel may result in termination of support for the awardee by NIMH. This special dispute resolution procedure in no way affect the awardee’s rights to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.

Sharing Data and Resources:

Applicant organization must comply with the NIH Grants Policy Statement, revised 10/01/2011 SECTION: 8.2.3  Sharing Research Resources.

Comprehensive data files of information, including but not limited to any and all molecular (genotyping, sequencing and other genomic) data generated under this award, are expected to be provided to dbGaP and/or the NIMH’s data management/cell repository facility as agreed under the data sharing plan submitted as part of the application, consistent with achieving the goals of this program.

Because the community standard for early data release is evolving, this proposed data release plan will be reassessed at the end of each funding period.

Progress Reviews

Progress of the project will be reviewed annually by the NIMH Project Officer at the time of each continuation application to assure that satisfactory progress is being made in achieving the project objectives, especially with respect to enrollment and quality of data collection, and that the site is following the procedures recommended and approved by the project Steering Committee. 

By acceptance of these awards, the awardees agree to abide by decisions and policies of the project Steering Committee and the other terms and conditions listed above or referenced in the Notice of Grant Award.

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 theNIH 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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Patrick Bender, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7190, MSC 9643
Bethesda, MD 20892-9643
Telephone:  (301) 443-6653
FAX:  (301) 402-4740
Email: patrick.bender@nih.gov

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
FAX: (301) 443-4720
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Victoria Carper
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda , MD 20892
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: carpervictoria@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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