Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

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

The goal of this Funding Opportunity Announcement (FOA) and the companion FOA, RFA-MH-17-200 (R34) "Pilot Research on Services for Transition Age Youth", is to stimulate research that develops and tests the effectiveness of service system interventions to improve functional and health outcomes for people with autism spectrum disorder (ASD) at two key life stages: transition from youth to adulthood, and adulthood. The Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research - 2013 Update (https://iacc.hhs.gov/strategic-plan/2013/index.shtml ) has framed objectives for research in these and other critical areas (IACC, 2013).

ASD begins in early childhood, causing varying degrees of impairment that can change over time and make delivery of effective services across the life span challenging. Critical service delivery challenges are evident at certain developmental stages. For example, exiting high school is associated with a steep decline in receipt of services by youth with ASD and, in addition, this is a time when disparities in service use based on race, socioeconomic status and mental ability have been documented. In addition, for adults with ASD, there is little empirical evidence to establish the effectiveness of services, and the extant research does not adequately address the range of service needs of adults with ASD and the challenges in coordinating across service sectors. Strategies to identify and provide services for previously undiagnosed adults with ASDs are also needed.

Service Needs of Adults with ASD

There is a growing need for research on how services and supports for adults with ASD can be structured so as to lead to optimal behavioral and functional outcomes. In addition to the impact of people diagnosed as children aging into adulthood, there is an increase in previously undiagnosed ASD being identified in adulthood, thus adding to demand for adult services. The IACC Strategic Plan - 2013 Update (https://iacc.hhs.gov/strategic-plan/2013/index.shtml) has framed research objectives for adult services in the areas of needs assessment, coordination across service systems, and provision of lifelong community supports for individuals and families. Within the framework of that Strategic Plan, NIMH issues this FOA to support pilot studies of services strategies to optimize the independence and functioning of adults with ASD across the heterogeneity of the disorder.

Many adults with ASD, including those with IQs within normal range, are significantly disadvantaged in the areas of social relationships, community housing supports, physical and mental health, and independent functioning. While the course of symptoms varies over developmental trajectories, continued impairment, particularly in social communication, persists into adulthood. Adding to the challenge of adult service provision is the heterogeneity of this population, including ongoing differences in brain maturation that extend into and continue to change through adulthood. Further, individuals with ASD face special challenges after exiting high school, when they often face new functional demands and have fewer services available to them.

In addition to addressing the deficits directly associated with ASD, there is also a need for effective strategies to address commonly co-occurring psychiatric and medical conditions which are often undetected and untreated, or poorly managed. To serve the goal of supporting independent functioning, strategies that include the participation of the effected individuals in the management of their comorbid conditions are needed. For adults with ASD, strategies to improve employment outcomes, and to avoid or improve the outcomes of police contact are also needed.

In addition, family often remains a source of support, and a venue for continuing development for adults with ASD, and such contributions must be factored into the development of service strategies. A particular emphasis is needed on care coordination and establishing the effectiveness of support for navigating multi-sector systems of care.

This FOA invites pilot studies in preparation for full scale tests of the effectiveness of service delivery or coordination strategies for adults with ASD across the heterogeneity of the disorder. However, given the intended pilot nature of the R34 activity code, conducting formal tests of outcomes or attempting to obtain an estimate of an effect size may not be justified.

Examples of responsive research projects include, but are not limited to, pilot studies in preparation for full scale R01s that will:

Test the effectiveness of specific services interventions (e.g., housing models; social- and independence-skills development programs; educational, vocational and employment programs and supports, etc.) for improving functional and behavioral outcomes among adults with ASD.

• Test the effectiveness of novel, existing, or adapted service delivery/coordination models in optimizing functional and health outcomes, independence, individual stability and continuity of care, and reducing disparities in access and utilization of services by adults with ASD.
• Test the effectiveness of combining and/or sequencing services (e.g., housing services, rehabilitation or compensatory strategies, individual or family support models, systems navigator models, etc.) in generalizing improvement in functioning and reducing negative outcomes (e.g., contacts with law enforcement; victimization; poor outcomes for comorbid conditions; unemployment, underemployment or social isolation; substance use, etc.)
• Test the effectiveness of provider- and systems-level strategies in facilitating receipt of services and coordination and continuity of care for adults with ASD (e.g., provider-targeted interventions to increase clinician attention to the universe of needs, organizational level interventions to develop cross-system collaboration among various aspects of the adult service systems, novel financing strategies to expand access to services).
• Test the effectiveness of strategies for identifying, treating and managing comorbid mental and/or physical disorders in adults with ASD.
• Test the effectiveness of strategies to identify undiagnosed ASD disorders in adulthood and engage those identified in services and supports in order to improve stability, behavioral and functional outcomes.
• Test the effectiveness of strategies to support individuals and families in accessing and navigating complex multi-sector systems of care, including increasing capacity to find or effectively advocate for services and to create informal supports and services for adults with ASD.

NIMH encourages the use of efficient research approaches, including existing platforms for subject recruitment, data collection, and analysis where possible. Such platforms might include the NIH-funded Clinical and Translational Science Awards (CTSAs) and the Mental Health Research Network (MHRN) and three networks funded by the Health Resources and Services Administration: Autism Intervention Research Network on Behavioral Health (AIR-B), Autism Intervention Research Network on Physical Health (AIR-P), and Developmental and Behavioral Pediatrics Research Network (DBP-RN).

Prospective applicants are encouraged to contact the Scientific/Research Contact for additional guidance. In addition, potential applicants are encouraged to use the NIH RePORTER tool to review project grants funded in response to prior Autism Services Research announcements, in order to avoid duplication of funded projects.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:
Email: NIMHreferral@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources: The description of the resources and environment should address how the study utilizes existing infrastructure (e.g., CTSAs, practice-based research networks, electronic medical records, administrative data bases, patient registries) or utilizes other available resources to increase the efficiency of participant recruitment and data collection or provide a justification in the event that such efficiencies cannot be incorporated.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Research Strategy: Applications should identify the target(s) of the proposed services intervention and provide evidence of the association between those targets and the outcomes of interest. The application should also provide evidence that: 1) the outcome measures have been validated or will be validated during the pilot work, 2) the outcomes measured include stakeholder relevant outcomes, 3) the intervention could be implemented in typical service settings using typically available personnel and resources, and 4) fidelity in intervention delivery will be monitored.

Applications should describe appropriate study milestones that are clearly defined for all of the study aims. The milestones should be feasible and quantifiable and described in the context of the study timeline. Potential challenges that may result in enrollment shortfalls should be discussed, along with and corresponding solutions to address enrollment problems.

Given use of the R34 mechanism, the application should propose developmental work that would enhance the probability of success in a subsequent R01, which might include working out the details of: the assessment, intervention and comparison group protocols; the randomization procedures (if appropriate); participant recruitment and retention strategies; and developing materials such as training manuals to ensure fidelity in delivery of the intervention. Therefore, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate.

All applications should also describe how the intervention strategy may reduce or eliminate racial, ethnic, gender or socio-economic disparities in the delivery of services to adults with ASD.

Significance:

The application should provide evidence that the intervention being developed could be implemented in typical service settings using typically available personnel and resources.

Approach: Applications should identify the target(s) of the proposed services intervention and provide evidence of the association between those targets and the outcomes of interest. The application should also provide evidence that: 1) the outcome measures have been validated or will be validated during the pilot work, 2) the outcomes measured include stakeholder relevant outcomes, 3) the intervention could be implemented in typical service settings using typically available personnel and resources, and 4) fidelity in service/intervention delivery will be monitored.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

In addition, individuals are expected to comply with the standard data requirements for ASD studies, as follows:

The NIH National Database for Autism Research (NDAR) houses research data of all types (genetic, imaging, clinical assessment, etc.) from human subjects involved in ASD studies, and is currently on track to receive data from tens of thousands of such subjects. NDAR’s first data release occurred in November 2010, making mostly clinical assessment data from over 10,000 research subjects available to qualified investigators. It is expected that in the next several years, ASD data from more than 90% of new investigations will be available in or through NDAR.

All research grants funded under this announcement will be expected to contribute any data collected on individual human subjects to NDAR, consistent with program goals for advancing autism research. To achieve program goals, data sharing is expected and NDAR will be involved to facilitate sharing activities. NDAR will function as a data repository for all funded projects. Central clinical coordination and local data management for data cleaning and entry and bio-statistical consulting will be the responsibility of the grantee(s). For more information on NDAR, please visit http://ndar.nih.gov/ndarpublicweb/.  The NDAR terms and conditions can be found in Guide Notice NOT-MH-09-005.  

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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 FOA supports the development and/or pilot testing of new or adapted interventions, including services interventions. Because this FOA supports exploratory/developmental studies, applications need not have as extensive background material or the degree of preliminary data that would be required to justify an R01 application. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Reviewers will emphasize in their evaluations the conceptual framework, level of innovation, and potential to significantly advance knowledge, understanding and public health impact.

The application should propose developmental work that would enhance the probability of success in a subsequent R01, which might include working out the details of: the assessment, intervention and comparison group protocols; the randomization procedures (if appropriate); participant recruitment and retention strategies; and developing materials such as training manuals to ensure fidelity in delivery of the intervention. Therefore, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate.

Reviewers will provide an overall impact 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).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is there evidence that the intervention could be implemented in typical service settings using typically available personnel and resources? Is it likely that the proposed research will lead to a firm conclusion about the feasibility of a regular research project grant or a full scale services/intervention trial? Is information provided about the scope and goals of the intended future work?

Is there evidence that the proposed developmental work is likely to enhance the probability of success in a subsequent R01? Do the study activities include working out details related to the future R01, including (as appropriate): the assessment, intervention and comparison group protocols; the randomization procedures (if needed); participant recruitment and retention strategies; and development of training manuals to ensure intervention fidelity; preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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? 

Does the application provide evidence of the association between the intervention target(s) and the endpoint(s) of interest? Are the outcome measures validated or being validated during the pilot work, and are stakeholder relevant outcomes included? Does the application describe the monitoring of fidelity in intervention delivery in community practice settings? Does the application provide justification for the sample size in terms of feasibility goals? Is there adequate description of the steps for intervention development/refinement and a clear rationale for the choice of methods proposed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 score, but will not give separate scores for these items.

Milestones and Timeline

Are appropriate, evaluative milestones clearly defined for the aims associated? Are the milestones feasible and quantifiable with regard to the specific aims and timeline? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

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 score.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Denise Juliano-Bult, M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: djuliano@mail.nih.gov

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

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

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