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

Advancing the Impact of Effective HIV/AIDS Prevention and Treatment Interventions (R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

New

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • July 26, 2011 - See Issuance of PAR-11-278 Discovery, Development, and Testing of Novel Interventions to Advance HIV Prevention and Care (R34).

Funding Opportunity Announcement (FOA) Number

PAR-11-274

Companion FOA

PA-11-271 - R01 Research Projects
PA-11-272 - R03 Small Grant Program
PA-11-273 - R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.242

FOA Purpose

The Division of AIDS Research (DAR) at the National Institute of Mental Health (NIMH) issues this Funding Opportunity Announcement (FOA) to outline priority areas for innovative research. This FOA encourages research designed to increase the impact of effective HIV/AIDS-related interventions for prevention and treatment. This FOA is informed by priority areas from the National HIV/AIDS Strategy, the NIH Office of AIDS Research (OAR) Plan for HIV/AIDS Related Research, as well as the NIMH Strategic Plan (Objective 4): To strengthen the public health impact of NIMH-supported research. That is, through research, evaluation, and collaboration, to develop the capacity of NIMH to help close the gap between the development of new, research-tested interventions and their widespread use by those most in need.

The two overarching goals of this FOA for support of the pilot clinical R34 grant activity are to encourage projects that will 1) improve the uptake of efficacious interventions and 2) conduct research to inform and enhance the effectiveness and efficiency of interventions, in order to maximize community impact.

Key Dates
Posted Date

July 26, 2011

Open Date (Earliest Submission Date)

August 7, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

May 8, 2014

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.


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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

The Division of AIDS Research (DAR) at the National Institute of Mental Health (NIMH) issues this announcement to outline priority areas for innovative research. This Funding Opportunity Announcement (FOA) encourages research designed to increase the impact of effective HIV/AIDS-related interventions for prevention and treatment. This FOA is informed by priority areas from the National HIV/AIDS Strategy, the NIH Office of AIDS Research (OAR) Plan for HIV/AIDS Related Research, as well as the NIMH Strategic Plan (Objective 4): To strengthen the public health impact of NIMH-supported research. That is, through research, evaluation, and collaboration, to develop the capacity of NIMH to help close the gap between the development of new, research-tested interventions and their widespread use by those most in need.

The two overarching goals of this FOA are to encourage projects that will:

This FOA encourages research that aims to evaluate the feasibility, acceptability and uptake of evidence-based approaches to improve public health for HIV/AIDS affected populations, and reduce risk behavior via implementation science, policy research, and other methods cited in the FOA, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale services study.  By using the R34 grant activity, we seek to encourage research on 1) development work on the implementation of efficacious or adapted interventions in different settings 2) evaluating interventions with demonstrated efficacy in broader scale dissemination or implementation research, or 3) innovative services research directions that require preliminary testing or development.  Additional guidance for the NIMH R34 mechanism is found at: http://grants.nih.gov/grants/guide/pa-files/PAR-09-173.html

BACKGROUND

Many interventions are available in the continuum of HIV prevention, HIV-testing, and HIV care (e.g., HIV treatment adherence). To maximize public health impact, significant progress is needed to deliver interventions more efficiently and effectively, transfer interventions from one setting or population to another, and to make better-informed choices between competing interventions. This implementation gap is impeding the success in prevention, care, and treatment programs in both the numbers of persons reached and the effect on health outcomes. Advances are urgently needed to reduce these unknowns and increase the public health impact of HIV/AIDS prevention, treatment, and care services.

To meet these aims, research is needed to address the following goals. The listed research questions are considered high priority, but this is not an exclusive list of potential important research directions.

1.  Studies to enhance the uptake of efficacious interventions

The goals and findings of such research – for example, projects focused on improving dissemination -- should be applicable across a broad range of targets, interventions, settings, and populations. Therefore, in the case of prevention of mother-to-child HIV transmission (PMTCT), the specific leverage points to improve uptake and implementation of PMTCT may differ from strategies needed to scale up male circumcision or increase retention in care rates among HIV patients; however there are common threads in these processes that are recognized through implementation science theory and methods. For example, there are social/structural, system, provider, and individual factors which interplay in the “cascade of steps” needed to successfully implement prevention and/or care programs.

a.         Dissemination research

Dissemination can be defined as the targeted distribution of information and intervention materials to a specific public health, clinical practice, or community audience.  The intent is to spread knowledge and the associated evidence-based interventions. Some examples of high priority studies in this domain are:

b.         Cost-effectiveness, modeling, and economic evaluations

To maximize health outcomes under constrained budgets, it is important to conduct evaluations of the cost-effectiveness of interventions under various scenarios, study the most effective distribution of available resources, and develop models to guide the allocation of expenditure across programs and population groups. Some examples of needed research in this domain are:

c.         Synthesize research to inform policy

Research can influence local, state, national, and global policies, and there are a variety of decision-makers for HIV/AIDS-related policy, including all levels of government, state and local AIDS planners, and third-party payors. Research syntheses such as meta-analyses and secondary analysis of existing datasets can be important tools to inform evidence-based policy-making. The following are examples of priority directions for research syntheses:

d.         Strengthen personnel and health systems

For sustained public health impact, the HIV-prevention and treatment personnel and infrastructure needs attention, including research on recruitment and training of personnel, organizational and provider behavior change, and the use of technology in health systems.

 2.   Studies to enhance the effectiveness and efficiency of interventions

In the U.S. and globally, interventions proven efficacious in clinical trials are implemented to reduce risk for HIV and enhance treatment. To evaluate and improve these interventions in real-world settings, NIH-funded research should, whenever feasible, leverage existing platforms, programs, or networks; a few examples of wider efforts are Centers for Disease Control and Prevention (CDC) HIV-prevention, the Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA) HIV/AIDS treatment sites, and President’s Emergency Plan for AIDS Relief (PEPFAR) prevention and treatment interventions. Applicants are encouraged to propose studies to build upon these activities.

Throughout the U.S., community-based organizations (CBOs), AIDS service organizations (ASOs), and faith-based organizations (FBOs) implement evidence-based interventions (EBIs) for populations at high-risk for acquiring or transmitting Human Immunodeficiency Virus (HIV), with support from CDC’s Diffusion of Effective Behavioral Intervention (DEBI) Project.

For the purpose of this FOA, implementation science and operational research are defined as systematic research that uses qualitative and/or quantitative methods to improve the delivery of services. For example, operational research can contribute to improvements by offering providers information and tools that can be used to increase the efficiency, effectiveness, and quality of the services they deliver, and the availability, accessibility, and acceptability of services desired by persons who use services.

a.         Implementation science and operations research

Research under the umbrella of implementation science does not intend to test the efficacy of a potential intervention; rather, this research seeks to advance the theory and methods which commonly underlie the implementation of a range of interventions.

b.         Determine the most effective combination approaches for interventions

UNAIDS (2010) provides a definition of combination HIV prevention: “The strategic, simultaneous use of different classes of prevention activities (biomedical, behavioral, social/ structural) that operate on multiple levels (individual, relationship, community, societal), to respond to the specific needs of particular audiences and modes of HIV transmission, and to make efficient use of resources through prioritizing, partnership, and engagement of affected communities.” Some priority research directions are:

c.         Comparative effectiveness

Comparative effectiveness research involves the direct comparison of existing interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances.

d.         Analyze the impact of policy changes on public health outcomes

HIV/AIDS-related services research is needed in rapidly evolving areas (e.g., changes in service systems, health care financing and policy) where there are opportunities for empirical study.

In particular, this FOA encourages innovative scientific partnerships between researchers and community or public partners (e.g., health care providers, payers, health authorities) who cannot delay policy or program changes -- to obtain baseline data related to such changes, and then evaluate impact on an ongoing basis.

Note: This FOA is not encouraging applications in the following areas:

International research in high resource countries or regions in countries that do not have a high or increasing prevalence rate of HIV are not a high priority.

Regarding studies to evaluate the adaptation of an efficacious intervention for a new population, NIMH has established clear decision rules for deciding whether to invest in adapting or extending an effective treatment or preventive intervention.  These are outlined in the 2010 NIMH National Advisory Mental Health Council (NAMHC) Report, “From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses. NIMH views research to adapt existing, effective treatments as a priority only when:

1. Through adaptation the treatment will be accessible to a subgroup (e.g., taking an adult treatment and making it developmentally appropriate for a young child).

2. The study tests the efficacy of an evidence-based treatment from one domain and adapts it for use in another (e.g., a successful prevention intervention is revised and tested to target treatment adherence, a smoking cessation intervention approach is adapted to a HIV-prevention intervention).

3. The study tests a revised intervention that is based on remediating documented mechanisms of non-response to the existing intervention. That is, there is theoretical and empirical support for the adaptation target (e.g., the adaptation changes a factor that has been associated with non-response, partial response, patient non-engagement, or relapse).  

4. New research generates predictors of benefits or adverse events that require validation that cannot be accomplished using existing data.

5. Evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, an aspect of care, or uptake in community/practice settings when compared to the existing intervention.

6. Clear explication of the mechanism by which a moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/ or biological data that support the mechanism hypothesis).

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Revision
Resubmission

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 number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any single year.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed three 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.   

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.

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:

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/PIs 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, NIH. Applications that are incomplete will not be reviewed.  

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.

The NIMH R34 clinical exploratory/developmental grant is a mechanism for supporting the development and/or pilot testing of new or adapted interventions, pilot testing of interventions with demonstrated efficacy in broader scale effectiveness trials, or conducting pilot innovative services research that requires preliminary testing or development. Because this is a clinical exploratory/developmental grant application, it need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will be instructed to place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R34 applications, but may be included if available.

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?  

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves 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?  

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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).

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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, 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: support@grants.gov

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)

Christopher Gordon, PhD
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-6100
Email:  cgordon1@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-3534
Email:  armstrda@mail.nih.gov.

Financial/Grants Management Contact(s)

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2805
Email: siscor@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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