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

Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

Reissue of PA-09-075

Related Notices

  • September 12, 2013 - See Notice NOT-MH-13-023. NIMH Announces Discontinuation of this FOA.
  • 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.

Funding Opportunity Announcement (FOA) Number

PAR-12-071

Companion FOA

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), seeks to support collaborative preliminary intervention studies to evaluate the feasibility, tolerability, acceptability and safety of novel mechanism drug candidates, promising investigational new drugs (INDs), or novel psychosocial strategies for the treatment of mental disorders and for obtaining the preliminary data needed as a pre-requisite to larger-scale (efficacy or effectiveness) intervention or services studies. This FOA should be used when at least two but no more than three sites from different Institutions/Organizations are needed to complete the study. The collaborating studies should be organized in order to increase sample size, accelerate recruitment, and/or increase sample diversity and representation. For a linked set of collaborative R34s, each site shall have its own Program Director/Principal Investigator and provide for a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting.

Key Dates
Posted Date

January 4, 2012

Open Date (Earliest Submission Date)

January 16, 2012

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

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Now Expired September 13, 2013 per NOT-MH-13-023), Originally January 8, 2015

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

Background

Significant advances in neuroscience, genetics, and basic behavioral science, together with technological developments, have provided a rich knowledge base for understanding pathophysiology, identifying new molecular targets for drug discovery, and developing rational pharmacotherapies and mechanistically informed psychotherapies for the treatment of serious mental illness. Drug discovery and development as well as development of tailored psychotherapies and new psychosocial treatment strategies are currently impeded by limited support for early human studies.

The purpose of this collaborative R34 Funding Opportunity Announcement (FOA) is to support the early phases (including proof-of-concept studies) of intervention development or adaptation, protocol development and preliminary pilot testing to support a full-scale (e.g., R01) efficacy or effectiveness study, and innovative services research. For the purpose of intervention development or pilot testing, "intervention" is broadly defined to include pharmacologic agents (including novel mechanism drug candidates and promising investigational new drugs, IND), medical devices, psychosocial approaches, or combination of the aforementioned approaches to treat or prevent mental disorders. Adaptation or extension of proven interventions should only be undertaken if there is a compelling rationale, supported by empirical evidence, that can be justified in terms of: (a) theoretical and empirical support for the adaptation target (e.g., the target has been associated with non-response, partial response, patient non-engagement, or relapse); (b) clear explication of the mechanism by which that moderator variable functions to disadvantage or advantage a subgroup (ideally, with behavioral and/or biological data that support the mechanism hypothesis); and (c) 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 existing intervention approaches. Treatment or prevention efforts may include treating disorders in the acute or later phases, such as continuation and maintenance; efforts to prevent relapse, side effects, or co-morbid symptoms and disorders; and rehabilitative efforts to reduce residual symptoms and/or enhance functioning.

This FOA specifically focuses on testing innovative pharmacologic, somatic, and/or psychosocial treatments directed at novel targets for mental disorders (e.g., mood disorders, schizophrenia, eating disorders, anxiety disorders, fragile x, autism).  It supports studies to rapidly assess safety and tolerability in normal human subjects and preliminary efficacy studies in the target patient population. Research projects directed towards ameliorating clinical dimensions of psychopathology embedded in DSM diagnostic entities, but not typically identified as the primary target of current clinical therapeutics, are also encouraged (see the Research Domain Criteria (RDoC) webpage http://www.nimh.nih.gov/research-funding/rdoc/nimh-research-domain-criteria-rdoc.shtml for more details).  The proof-of-concept, early phase II, or other studies supported under this FOA, such as clinical dose optimization, pharmacokinetics, and pharmacodynamics studies, should determine with reasonable certainty whether or not an intervention is sufficiently safe and feasible to warrant further clinical development.  This collaborative R34 award mechanism may also be used to rapidly acquire data on currently used (off label) medications and other interventions that show promise but lack preliminary data on side effects, safety, and/or efficacy. This FOA should be used when at least two but no more than three sites from different institutions/organizations are needed to complete the study. The collaborating studies should be organized to increase sample size, accelerate recruitment, or increase sample diversity and representation. For a linked set of collaborative R34s, each site shall have its own Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and provide for a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting.

Applications submitted in response to this FOA should propose the developmental work to be performed that would enhance the probability of success in a larger trial. Pilot intervention studies submitted in response to this FOA do not necessarily need to be scaled down Randomized Controlled Trials (RCTs) that propose formal tests of intervention outcomes. Indeed, depending on the stage of intervention development, the R34 project might not involve randomization, but rather might focus on earlier stages such as the operationalization of an intervention protocol and corresponding manual and/or pilot testing of the experimental intervention in a case series with a sample drawn from the target population. Most importantly, the R34 should propose the developmental work to be performed that would enhance the probability of success in a larger trial. This is best done by working out the details of the experimental protocols, including the assessment protocol, the experimental intervention protocol, as well as the comparison intervention protocol and randomization procedures (if appropriate); examining the feasibility of recruiting and retaining participants into the study conditions (including the experimental condition and the comparison condition, if relevant); and developing supportive materials and resources. Accordingly, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate.

The topics listed below are examples of studies that fall under the scope of this FOA. The list is not exhaustive; it is expected that investigators who respond to this FOA will identify additional important topics.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Revision

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

Each set of linked collaborative R34 applications may not exceed three applications. Direct costs are limited to $450,000 per application over an R34 three-year period, with no more than $225,000 per application in direct costs allowed in any single year.

Award Project Period

The total project period for an application submitted in response to this FOA 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 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. 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.

Application Title (required format)

In order to allow NIH to identify a group of applications as a related set of collaborative R34s, the titles to each R34 of a set, must have the following format: a 1/N indicator + Identical title (e.g., 1/3-Multisite Comparison of Drug A vs. Drug B for Treatment of Disorder X, where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3 and 3/3,) Titles may not exceed 80 characters in length including the tag, e.g., 1/3, at the beginning of the title.

SF424(R&R) Other Project Information Component (required)

A list of the collaborative applications as described for the PHS398 Cover Letter must also be included in Item 12, Other Attachments. The information provided in this attachment MUST include a listing of all the applications that are a part of the set of collaborative R34s being submitted, including for each: 1) the PD(s)/PI(s) name, 2) the Title (including the tag, e.g., 1/3), and 3) the Applicant Institution. Each site should submit an identical listing. This file should begin with a heading called Collaborative Applications. When saving the file, please name the file Collaborative_Applications as well, to ensure this section of the application is bookmarked appropriately.

Applicants are advised that the Resources section, which should address not only physical resources, but also the intellectual and collaborative resources for executing the project [see Section 4.4, Item 10. “Facilities & Other Resources” of the SF424 (R&R)] can be utilized to address relevant Resource-related collaborative issues. Instructions for this section include the following language:

PHS398 Cover Letter Component (required)

The Cover Letter is a one-pdf file attachment only. Therefore, it must include the information requested below on the collaborative sites, as well as, where required, the IC approval information on applications requesting $500,000 or more in combined direct costs. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative R34s being submitted, including for each: 1) the PD(s)/PI(s) name, 2) the Title (including the tag, e.g., 1/3), and 3) the Applicant Institution. Each site should submit an identical listing.

Appropriate Required Budget Component

This FOA uses the modular as well as non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget Component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the SF424 R&R Budget Component.

PHS 398 Research Plan Component

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

The collaborative mechanisms currently require an OVERVIEW section that is part of the one-page specific aims attachment to the SF424 application form. This OVERVIEW section should be identical for all applications that are linked together for the collaborative R34. The requirements of the OVERVIEW are as follows:

The overview should provide an overall rationale for applying as a collaborative study; the role of each site; the approach to project management; and elements unique to any of the sites.

This information is required in order to address the sixth review criterion, COLLABORATION. This criterion is not scored separately but is incorporated within the Overall Impact (see Section V.2. Review and Selection Process).

The application from each site must contain an identical PHS398 RESEARCH STRATEGY - Item 3. The Research Strategy must describe those aspects of the project that are common to all sites of the collaboration. Investigators should use this section to describe the research procedures or protocol, the study population from which samples are drawn, resources, data analyses, and any other characteristics that support each site’s importance to the overall project. Collaborative R34 applications proposing multi-site clinical trials must implement a common clinical research protocol, in parallel, across all collaborative studies/applications and recruitment of subjects should take place at all collaborative sites. All variations in the research plan between sites, no matter how minor, should be highlighted with the heading "ELEMENTS UNIQUE TO THIS SITE." In this subsection PD(s)/PI(s) should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, etc.

Applications must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control. The PD(s)/PI(s) may or may not wish to designate a Steering Committee or other decision making body, or identify one individual as the contact person for the group as a whole, for purposes of NIMH correspondence. Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use research materials and data, or other means of distributing research materials to the wider scientific community, and a means of arbitrating disagreements on publication and other issues should be included in the application.

Any site that contracts out some portions of this work should list this fact under "ELEMENTS UNIQUE TO EACH SITE," and provide a full description of the nature, purpose and oversight of this contractual arrangement.

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:

·         Investigators seeking $500,000 or more in COMBINED direct costs in any year should include a brief 1-paragraph description of how final research data will be shared.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

 This FOA requires the use of the linked NIH Collaborative R34 award mechanism. Multiple PD(s)/PI(s) are allowed on any single application and the policy for doing so is included in this FOA. Because the Collaborative R34 mechanism already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PD(s)/PI(s) on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should NOT be designated as multiple PD(s)/PI(s) on all applications of a collaborative set.

Requests of $500,000 or more for combined direct costs in any year

Applicants requesting $500,000 or more in combined direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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.

For this particular announcement, note the following:

The collaborative R34s Pilot Studies of Innovative Treatments in Mental Disorders grant is a mechanism for supporting pilot testing of new or adapted interventions, as described under Research Objectives. Because this is a preliminary study to a hypothesis-testing study, it need not have extensive background material or pilot data 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 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; however, they 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(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?   

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?   

Collaboration

Does the research plan justify the need for a collaborative multi-site project, using this FOA? Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results? Are there adequate plans for shared decision making among PD(s)/PI(s) with regard to personnel, clinical decisions, changes in study protocol, and authorship?

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.

In line with a major purpose of this FOA, namely to evaluate the feasibility, tolerability, acceptability and safety of novel approaches to improving mental health, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study: How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full scale clinical trial? Is information provided about the scope and goals of intended future work?

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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: 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)

Mi Hillefors, M.D., Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
Telephone: (301) 443-1692
Email:  mi.hillefors@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
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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