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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Pilot Intervention and Services Research Grants (R34)  

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

Reissue of PAR-09-173

Related Notices

  • February 24, 2014 - See Notice NOT-MH-14-009. Notice to Discontinue Participation of NIMH.
  • 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-12-279

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.242, 93.273

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research on 1) the development and/or pilot testing of new or adapted interventions, 2) the adaptation and/or pilot testing of interventions with demonstrated efficacy for use in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development. The R34 award mechanism provides resources for evaluating the feasibility, tolerability, acceptability and safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) intervention or services study.  NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span.  NIAAA prevention, treatment, and services research is aimed at preventing or ameliorating alcohol use disorders, related emotional or behavioral problems, and the co-occurrence of other mental, physical, and substance abuse problems, HIV/AIDS, and the functional consequences of these problems across the life span..

Key Dates
Posted Date

September 7, 2012

Open Date (Earliest Submission Date)

September 9, 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, 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

(Now Expiring May 8, 2014 per NOT-MH-14-009), Originally September 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

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research on 1) the development and/or pilot testing of novel or adapted interventions, 2) the adaptation and/or pilot testing of interventions with demonstrated efficacy for use in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development, as detailed in the sub-headed sections that follow.  The R34 award mechanism provides resources for evaluating the feasibility, tolerability, acceptability, and safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale intervention (efficacy or effectiveness) or services study.

For the purpose of intervention pilot research, "intervention" is broadly defined to include psychosocial, pharmacologic, somatic or combination approaches to prevent the onset of disorder; efforts to treat disorder in the acute and 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 mechanism is also intended to support innovative pilot services research to identify mutable factors that impact access, utilization, quality, and outcomes of mental health services and to inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery. 

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, as described below, 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.  However, given the intended pilot nature of the R34 mechanism, conducting formal tests of outcomes or attempting to obtain an estimate of an effect size is often not justified.  Given the limited sample sizes typically supportable under this pilot study mechanism, the variability in the effect sizes obtained is often so large as to be unreliable. Thus, using these potentially unstable effect size estimates in power calculations for larger studies, without regard to clinical meaningfulness, is not advisable.

Likewise, pilot services studies that propose non-RCT designs do not need to be a reduced scope version of the anticipated larger study, but should instead attempt to develop and refine the research strategies to be utilized in the subsequent definitive study.

NIMH intervention and services research is aimed at preventing or ameliorating mental disorders, emotional or behavioral problems, the co-occurrence of mental, physical and substance abuse problems, HIV infections, and the functional consequences of these problems across the life span.  Across all mental health intervention/services research areas, intervention and services research that addresses research objectives outlined in the NIMH Strategic Plan are encouraged.  Additional priorities for mental health research that is specifically focused on intervention research are detailed in the NAMHC Workgroup Report "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses."  Priorities for services research are addressed in the NAMHC Workgroup Report “The Road Ahead: Partnerships to Transform Services."

NIAAA prevention, treatment, and services research is aimed at preventing or ameliorating alcohol use disorders, related emotional or behavioral problems, and the co-occurrence of other mental, physical, and substance abuse problems, HIV/AIDS, and the functional consequences of these problems across the life span.

Potential applicants are encouraged to contact program staff as far in advance as possible to discuss the match between potential research applications and current NIMH and NIAAA priorities.

1.  Development and Pilot Testing of Novel or Adapted Interventions

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. 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. 

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 (see the NMHAC Workgroup Report, "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses, Recommendation 2.4.1, page 19, for additional guidance regarding the empirical justification for intervention adaptations and augmentations).

Intervention development can be considered to have three stages:  1) conceptualizing an intervention based on theory and empirical research, 2) developing and standardizing the intervention, and 3) pilot testing.

Stage 1.  When proposing a novel or adapted intervention, the application should explicate a clear conceptual link between relevant psychological or behavioral factors, various intervention components being proposed (including a description of the purported mechanisms of action by which these components are hypothesized to have an effect), and their relationship to the particular aspects of outcome that are being targeted.  The need for a new or adapted intervention should be strongly justified in terms of the base-rate and public health significance of the target problem, the limitations of existing intervention approaches, and the expected increment in effect sizes in comparison to currently available intervention approaches.  The justification for a new or adapted intervention might in part be based on data from prior research describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, or relapse.  Accordingly, interventions might be designed or adapted to address conditions for which efficacious interventions are lacking or to target factors that have previously been identified with poor responses to existing approaches.  High priority will be given to applications that demonstrate the systematic translation of basic behavioral and neurobiological processes (e.g., cognition, memory, attention, emotion, personality) into applied interventions.  Attention should also be given to the effects of these interventions with underserved populations in disparate social, economic, cultural and environmental contexts.  Applications that propose adaptations or augmentations of currently available treatments for new subpopulations without strong empirical justification will be considered low priority.

Stage 2.  Standardization of an intervention primarily involves development or adaptation of the intervention protocol (e.g., psychotherapy manual, medication dosing schedule), including iterative refinements based on feedback from patients, care providers, and other investigators.  This stage might also involve refinements to assessment strategies (e.g., measures to determine inclusion/exclusion; measures to assess psychiatric and other outcomes, such as indices of functioning and cost; and measures to assess acceptability of the intervention protocol, fidelity of provider implementation, and client/patient adherence).

Stage 3.  Pilot and feasibility studies involve testing and further refining the intervention manual and measures developed in earlier stages of intervention development/refinement.  Typically, data are gathered to examine the feasibility of:  identifying, enrolling, and retaining participants; implementing the experimental intervention (and comparison condition, if relevant); and implementing the assessment protocols, including examining feasibility of measures for assessing inclusion/exclusion, fidelity of intervention delivery, mediators/moderators of response, and outcomes.  Depending on the characteristics of the disorder or target population, the nature of the intervention, and the stage of research program, pilot testing may take various forms.  Pilot testing might involve systematic study of an uncontrolled case series or use of a small randomized pilot trial to explore feasibility of both the experimental intervention and the control condition that will be used in the subsequent definitive trial.  Under other circumstances, alternative designs might be appropriate (e.g., quasi-experimental designs).  The application should provide a clear justification for the type of experimental design chosen.  In summary, the goal of this phase of research is to propose the most rigorous means of collecting data (in light of ethical or other limitations) that will inform a larger, more definitive test of the intervention in the future.

Given that boundaries between these three stages are not discrete, investigators may propose research activities or methods from one or more of the above-noted stages. However, investigators are not expected to necessarily complete all stages of development during the 3-year duration of the award.  Rather, the goals of the study should be clearly outlined and related to specific aims.  Importantly, applications should propose feasible goals that can be accomplished within the time and funding constraints of this award while considering the aim of accomplishing the prerequisites for conducting a larger (e.g., R01) study.

Examples of possible NIMH-relevant intervention development or adaptation studies include, but are not limited to:

In addition to the above, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in intervention development or adaptation studies including, but not limited to:

2.  Adaptation and Pilot Testing for Effectiveness

The principal aim of effectiveness (or public health-oriented) research is to determine whether interventions with demonstrated efficacy under tightly controlled conditions can have a measurable beneficial effect when implemented in less precisely controlled circumstances with more heterogeneous populations, providers and settings.  Typically, these studies have broader inclusion (i.e., relatively few exclusion criteria) and outcomes often include variables such as functioning (school, work, interpersonal, etc.), quality of life, mortality, institutionalization, costs, and health care resource use, in addition to measures of psychiatric morbidity.

When conducting effectiveness research on an intervention with previously demonstrated efficacy, information regarding its initial degree of "fit" within an applied setting (e.g., specialty or primary care, school or work site) and the iterative process that is expected to occur when altering the intervention for successful implementation within this setting should be articulated.  Accordingly, pilot effectiveness research can be considered to have stages of research that parallel the stages of novel intervention development noted above, including: (stage 1) an initial stage where characteristics of typical patients, provider, and the community/practice setting in which the intervention will be transported are systematically considered; (stage 2) a phase in which adaptations to improve the fit of the intervention are operationalized and incorporated in intervention manuals and materials; and (stage 3) a stage in which the intervention is pilot tested.  As with studies proposing novel intervention development, effectiveness pilot studies using the R34 mechanism are not necessarily expected to include all of these stages, but rather, the particular stages of intervention adaptation and pilot testing should be clearly outlined and justified, and the application should include a well-articulated plan for collecting feasibility data that will inform a subsequent definite effectiveness study.

Examples of possible NIMH-relevant effectiveness research questions include, but are not limited to:

In addition to the above, NIAAA is interested in effectiveness research questions including, but not limited to:

3.  Innovative Services Research

This funding opportunity is also intended to encourage applications to facilitate innovative services research directions that require preliminary testing or development.  Such pilot studies might include research on mutable factors that impact access, utilization/engagement, quality, and outcomes of mental health services, or inform or pilot test patient-, provider-, organizational-, or policy- level services interventions to improve care quality, coordination, or delivery.

Research in these areas may require novel or mixed methodologies and/or innovative statistical approaches.  Studies designed to develop and/or pilot test novel service interventions or service delivery models might reflect one or more of the three stages of intervention development described in the "Development and Pilot Testing of New or Adapted Interventions" section of this Program Announcement. The feasibility of proposed service interventions and their potential for widespread uptake and sustainability should be carefully considered at the outset to maximize public health impact.  Likewise, observation of factors influencing implementation and dissemination should be addressed in the pilot work, wherever possible.

Examples of NIMH-relevant services research applications in this area include, but are not limited to:

In addition to the above, NIAAA is interested in services research applications in the areas of:

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

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 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.

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.

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.

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 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(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?

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 NIMH or NIAAA,, 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 or the National Advisory Council on Alcohol Abuse and Alcoholism. 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)

For inquiries focused on mental health intervention/services research applications:

Joel Sherrill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-2477
Email:  jsherril@mail.nih.gov

For inquiries focused on NIMH-relevant HIV/AIDS-related applications:

Dianne Rausch, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-6100
Email:  drausch@mail.nih.gov

For inquiries focused on NIAAA-relevant applications:

Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-5820
Email: droach@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

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 451-2067
Email: ranga.srinivas@nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-8811
Email:  rclaycam@mail.nih.gov

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone:  (301) 443-4704
Email:  jfox@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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