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

Services Research for Autism Spectrum Disorder across the Lifespan II (ServASD II):  Pilot Research on Services for Transition-Age Youth (R34)

Activity Code

R34 Planning Grant

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

RFA-MH-17-200

Companion Funding Opportunity

RFA-MH-17-205, R34 Planning Grant Program

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

93.242 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support research to develop and pilot test strategies to assist transition-age youth with autism spectrum disorder (ASD) and their families or caretakers in planning for and smoothly transitioning into adult functioning and adult services.  The ultimate goal is to develop models for transition to adult supports and services that effectively prevent lapses in services and supports; enhance functioning in community settings such as educational, social, familial, and other settings; maintain or improve health, safety, and quality of life; and reduce or maintain reductions in ASD-related symptoms.  For the purposes of this FOA, "transition-age youth" refers to individuals with ASD who, in the coming months or years, will age out of the services and supports delivered via K-12 education and other child/adolescent service systems.  This definition is intended to encompass variability in the youth-to-adult transition period and to accommodate individual differences that may influence the nature and duration of the transition process.

The purpose of the R34 award mechanism is to provide resources for evaluating the feasibility, tolerability, acceptability and safety of novel approaches to improving outcomes, modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) services study.  This FOA runs in parallel to a companion FOA also targeting autism services research: RFA-MH-17-205, which targets services strategies to optimize capacity for independent functioning in adults with ASD. 

Key Dates
Posted Date

October 28, 2015

Open Date (Earliest Submission Date)

January 3, 2016

Letter of Intent Due Date(s)

January 3, 2016

Application Due Date(s)

February 3, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2016

Advisory Council Review

October 2016

Earliest Start Date

December 2016

Expiration Date

February 4, 2016

Due Dates for E.O. 12372

Not Applicable

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.

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 and Rationale

The goal of this Funding Opportunity Announcement (FOA) and the companion FOA, RFA-MH-17-200 (R34) "Pilot Research on Services Strategies for Adults with ASD", 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 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 causes varying degrees of impairment that can change over time and make delivery of effective services across the life span challenging.  For example, exiting high school is often associated with a steep decline in receipt of ASD-related services and, in addition, this is a time when disparities in service use based on race, socioeconomic status and mental ability have been documented.  Existing research is insufficient to inform the delivery of effective transition services and the coordination of services across delivery sectors. 

Transition to Adulthood for Youth with ASD

Transition to adulthood involves changes in available structure and support, and the expectation of more independent functioning.  Such transition is even more challenging for youth with ASD who may struggle with communication and social interactions, face intellectual challenges, have physical or behavioral health comorbidities, and require continuing assistance with activities of daily living.  While autism symptoms may improve over time, research shows that improvement may slow sharply after exit from high school, when youth can become more socially isolated and will age-out of services available through the child and adolescent service system.  This highlights the need for effective transition planning to achieve optimal outcomes.

There is, however, little empirical evidence to inform transition decision-making across the heterogeneity of symptoms, abilities, and needs, or even on how best to engage and sustain this age group in treatment and services.   Empirical evidence is needed on how to accomplish optimal timing and coordination of supports and services, family or care-taker involvement and support, and the role of multiple service providers in maintaining or improving health, behavioral and functional outcomes.  Strategies to avoid disruptions in care financing streams are also critical to maintaining continuity of care.

Consequently, there is need for the development and testing of transition-planning strategies that avoid or minimize documented adverse outcomes.  Studies of interest include pilot work leading to future full scale tests of the effectiveness of transition strategies in ensuring continuous engagement in needed services to maintain and improve behavioral, social, and vocational or academic functioning.  All intervention strategies proposed under this funding opportunity should include strategies to reduce or eliminate documented racial, ethnic, gender or socio-economic disparities in the identification of ASD and the receipt of services. 

NIMH also encourages applications, where possible, to make use of existing practice research infrastructures – including, but not limited to, the NIH-funded Clinical and Translational Science Awards and the Mental Health Research Network (CTSAs) 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).

Specific Areas of Research Interest

This FOA invites applications to conduct pilot work preliminary to the testing of service interventions that actively engage transition-age youth with ASD and their families or care-takers in planning for and transitioning to optimal functioning in adult life.  For the purposes of this FOA, transition-age youth refers to individuals with ASD who are within two years of aging out of the K-12 educational system and other child/adolescent service systems. 

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

  • Develop and test provider and systems-level strategies to ensure coordinated, continuous care during transition to adult services (e.g., interventions to increase provider attention to transition planning, strategies to develop cross-system collaboration, novel financing strategies to bridge from child and adult service systems).
  • Enable providers to tailor transition strategies to an individual's intellectual abilities, health and housing needs and key functional skills so as to eliminate disparities in the receipt of services. 
  • Optimize collaboration among education and other service systems (e.g., vocational rehabilitation, health care system, Social Security Administration, Medicaid, state-level agencies, independent living programs, etc.) to enable optimal independence and functioning.
  • Reduce and prevent disparities in postsecondary education, functioning, health care access, and independent living, including disparities based on socioeconomic status, race or ethnicity, intellectual ability, or functional impairment.
  • Develop and test strategies to prevent lapses in acquired skills and behaviors and to interrupt negative trajectories, including preventing or ameliorating contact with the criminal justice system, treating and managing comorbid medical and/or psychiatric disorders, reducing victimization, and improving housing outcomes.

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.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMH intends to commit $1.3 million in FY 2017 to fund 5-6 awards in response to this FOA and the companion FOA. 

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 a 3-year period, with no more than $225,000 in direct costs allowed in any single year.

Award Project Period

The total project period may not exceed 3 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

  • 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
Foreign Institutions

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

Required Registrations

Applicant Organizations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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.

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.

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).
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, 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.

Letter of Intent

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

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

  • 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:

E-mail: NIMHreferral@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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.

Other Attachments: Applicants are encouraged to upload a single attachment that includes the following information, using the headers below.

I. Participant Recruitment and Retention Procedures: Applications should provide a clear description of:

  • Recruitment and referral sources, with anticipated participant yield from each;
  • Procedures to monitor enrollment and retain participants;
  • Strategies to ensure a diverse, representative sample;
  • Strategies to address enrollment shortfalls (e.g., additional outreach, alternate referral sources);
  • Evidence of the feasibility of meeting enrollment targets

II. Study Milestones and Timeline: Applications should provide a clear description of the following:

A proposed timeline for quantifiable study milestones such as: (a) finalizing study procedures and training staff; (b) finalizing the intervention manual and assessment and fidelity protocols, as appropriate; (c) enrolling 25%, 50%, 75% and 100% of the sample; (d) completing follow-up data collection and data quality checks; (e) analyzing results; and (f) preparing de-identified data for data sharing as appropriate. The proposed milestones should describe specific, measurable markers, which can be used as indicators of satisfactory progress.

SF424(R&R) Senior/Key Person Profile

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

Senior/Key Personnel should demonstrate their experience and expertise at collaborating with community practice partners/providers, consumers, and relevant policy makers to conduct effectiveness studies.

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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.  Some description of the future R01 should be included.

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.

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 transition age youth with ASD.       

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.  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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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.

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 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.

Post Submission Materials

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

Section V. Application Review Information

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.

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 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 focus their evaluations on 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.

Overall Impact

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).

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?

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?

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

Innovation

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

Approach

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

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?  

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 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)?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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 score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 National Institute of Mental Health 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.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to 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.

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 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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
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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone:  301-443-8811
Email: tkees@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 Part 75.

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