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 (ServASD): Pilot Research on Services for Transition-Age Youth (R34)
Activity Code	R34 Clinical Trial Planning Grant Program
Announcement Type	New
Related Notices	October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. 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	RFA-MH-14-101
Companion Funding Opportunity	RFA-MH-14-100, R01 Collaborative Research Project Grant RFA-MH-14-102, R34 Clinical Trial Planning Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
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 in planning for and smoothly transitioning into adult functioning and adult services. The ultimate goal is to develop a model for transition to adult supports and services that effectively: prevents lapses in services and supports; enhances functioning in work, education, social, familial, and other settings; maintains or improves health, safety, and quality of life; and/or reduces or maintains reductions in ASD-related symptoms. For the purposes of this FOA, "transition-age youth" refers to individuals with ASD who, within two 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. This FOA will use the R34 activity code. The purpose of the R34 activity code 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 is published in parallel to two companion FOAs also targeting autism services research: RFA-MH-14-100, which targets early identification and expedited evaluation of ASD plus linkage to services within the first two years of life and RFA-MH-14-102, which targets services strategies to optimize capacity for independent functioning in adults with ASD.

Posted Date	May 30, 2013
Open Date (Earliest Submission Date)	September 22, 2013
Letter of Intent Due Date(s)	September 22, 2013
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 22, 2013, by 5:00 PM local time of applicant organization. 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	February/March 2014
Advisory Council Review	May 2014
Earliest Start Date	July 2014
Expiration Date	(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 23, 2013
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.

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 FOAs, RFA-MH-14-100 (R01), Research on Early Identification and Linkage to Services and RFA-MH-14-102 (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 three key life stages: early childhood, transition from youth to adulthood, and adulthood. The 2012 Strategic Plan of the Interagency Autism Coordinating Committee has framed objectives for research in these and other critical areas (IACC, 2012).

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. First, only a fraction of children with ASD are identified in early childhood (Shattuck et al., 2009), a time when early intervention can ameliorate impairment (Lord & McGee, eds., 2001; Dawson et al., 2012). Second, exiting high school is associated with a steep decline in receipt of services by youth with ASD. In addition, this is a time when disparities in service use based on race, socioeconomic status and mental ability have been documented. (Shattuck, et al., 2009) Finally, extant research does not adequately address the range of service needs that result from varying levels of disability and the challenges in coordinating across service sectors. Strategies to identify and provide services for previously undiagnosed adults with ASDs are also needed.

Transition to Adulthood for Youth with ASD

The transition from youth to adulthood is marked by changes in available structure and supports, new challenges in the areas of work and postsecondary education and the expectation of more independent functioning. This transition period is even more challenging for youth with ASD who struggle with communication and social interactions, may be intellectually challenged, have physical and/or behavioral health comorbidities (e.g., gastrointestinal problems, Attention Deficit Disorder), and rely more heavily on caregivers for assistance with daily living. While multiple studies show that autism symptoms tend to improve over time, from early childhood to adulthood (e.g., Fecteau et al., 2003; McGovern & Sigman, 2005; Howlin et al., 2000), recent research also shows that these improvements slow sharply upon exit from high school, when transition age youth also become socially more isolated (Taylor & Seltzer, 2010), and when they age-out of services available through the child and adolescent service system.

While virtually all youth with ASD can continue to benefit from services and supports from many systems, including healthcare, education, vocational and social services (Lord & McGee, eds., 2001), transition to adulthood is a time of risk for disruption or cessation of such services, leading to lapses in previously achieved skills. Research suggests several factors may particularly contribute to risk. As many states use IQ as a basis for determining adult eligibility for publicly funded developmental disability services, the many transition-age youth with ASD who do not qualify for those services face a significant challenge in continuing to receive the assistance needed to function in adulthood. In addition, a nationally-representative study found that young adults with ASD were less likely to be enrolled in postsecondary education or to have a paid job compared with peers from other disability groups (Shattuck & Narendorf, et al., 2012). There is also evidence that race, socioeconomic status, and cognitive capability contribute to poorer post high school outcomes (Shattuck et al., 2011; Taylor & Seltzer, 2010). These findings highlight the critical need for intensive transition planning and service coordination for youth with ASD in order to achieve optimal outcomes as they move into adult services.

Little is known, however, about the special issues related to engaging and sustaining this age group in treatment and services issues that are further complicated by the heterogeneity in impairment and abilities, and by the multiple systems that may be relevant to an individual’s service needs. In particular, the optimal timing and coordination needed to systematically engage youth, their families, and multiple service providers in transition planning has not yet been determined, and the effectiveness of individual services and service packages in maintaining or improving health, behavioral and functional outcomes must be established. Strategies to effectively avoid disruptions in care financing streams will be critical to achieving service coordination and maintaining continuity of care. Consequently, there is need for the development and testing of the effectiveness of services interventions that actively engage transition age youth with ASD and their families in planning for and transitioning from child and adolescent services to the adult service system without disruptions in services or financing and without related adverse outcomes. Studies of interest include relevant pilot work leading to the future testing of school-based and other transition strategies that ensure that all youth with ASD are continuously engaged in appropriate services as they leave adolescence so that their behavioral, social, and occupational skills continue to advance as fully as possible into adulthood. All proposed interventions should include strategies to reduce or eliminate racial, ethnic, gender or socio-economic disparities in the identification and treatment of persons with ASD.

NIMH 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).

This FOA invites applications to conduct pilot work preliminary to the testing of service system interventions that actively engage transition-age youth with ASD and their families 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 within two 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 R34 application should propose developmental work that would enhance the probability of success in an R01, which might include: working out the details of the experimental protocols including the assessment protocol, the 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 activity code, conducting formal tests of outcomes or attempting to obtain an estimate of an effect size may not be justified. Applicants are encouraged to briefly describe the specific R01 to which the proposed study is intended to lead.

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 that facilitate transition planning and help ensure coordinated, continuous care as individuals with ASD transition from child/adolescent- to adult-level service systems (e.g., provider-based interventions to increase clinician attention to transition planning needs, strategies to develop cross-system collaboration among providers in youth- and adult- service systems, novel health-care financing strategies to traverse child/adolescent- and adult- systems)
• Tailor transition strategies based on youths' intellectual abilities and key functional skills so as to eliminate disparities in the receipt of services after graduation from high school and to ensure successful transition to adulthood for all youth with ASD.
• Optimize collaboration among education and other service systems (e.g., vocational rehabilitation, health care system, Social Security Administration, Medicaid, state-level agencies, independent living centers, adult services, integrated employment) to help transition-age youth with ASD plan for and realize the most productive, independent, and symptom-free adult life possible.
• Reduce and prevent disparities in postsecondary education, employment, health care access, and quality of life for transition-age youth with ASD, including disparities based on socioeconomic status, race or ethnicity, intellectual ability, or functional impairment.
• Develop and test strategies to identify and serve transition-aged youth with ASD in a wide variety of service system settings in order to prevent lapses in acquired skills and behaviors and to interrupt negative trajectories (e.g., to address mental health needs and prevent or ameliorate interactions with the criminal justice system; to treat comorbid psychiatric disorders, reduce victimization, and improve housing outcomes).

The ultimate goal of this initiative is to develop service strategies that enable youth with ASD to transition to the adult service system without lapses in care and supports. Outcomes of interest include maintenance or improvement in functioning in work, education, social, familial, and other settings; maintenance or improvement in health, safety, and quality of life; and reduction or maintaining reductions in ASD-related symptoms. Such models will require a high degree of coordination among providers of medical, mental health, education, employment, vocational, and social support services, state disability programs, third party payers, and families in community settings. Successful applications will conduct pilot work in preparation for testing a service systems intervention that can generalize broadly to many regions of the U.S. From the early stages of development, these interventions should include features for rapid dissemination, adoption, and implementation in communities, thus facilitating the transition from research to practice. This FOA encourages applications that place a premium on potential for impact, meaning potential for a demonstrable benefit in terms of (a) broad reach across services and subgroups of youth on the autism spectrum; (b) seamless transition out of the child/adolescent service system and into the adult service system without disruptions in services and without related adverse outcomes; and (c) reduction of disparities in linkage to and receipt of services. Wherever possible, applicants should use efficient research approaches, including use of existing platforms for subject recruitment, data collection, and analysis.

Prospective applicants are encouraged to contact program staff for additional guidance.

Dawson G, Jones EJH, Merkle K, et al. Early behavioral intervention is associated with normalized brain activity in young children with autism. Journal of the American Academy of Child and Adolescent Psychiatry. 2012; 51(11): 1150-9.

Fecteau S, Mottron L, Berthiaume C, and Burack JA. Developmental changes of autistic symptoms. Autism. 2003; 7(3): 255 268.

Howlin P, Mawhood L, and Rutter M. (2000). Autism and developmental receptive language disorder a follow-up comparison in early adult life II: Social, behavioural, and psychiatric outcomes. Journal of Child Psychology and Psychiatry, and Allied Disciplines. 2000; 41(5): 561 578.

Interagency Autism Coordinating Committee. IACC Strategic Plan for Autism Spectrum Disorder Research. Washington (DC): US Department of Health and Human Services. 2012.

Lord C, and McGee JP, eds. (2001). Educating Children with Autism. Washington (DC): National Academy Press, National Research Council: Division of Behavioral and Social Sciences.

McGovern CW, and Sigman M. Continuity and change from early childhood to adolescence in autism. Journal of Child Psychology and Psychiatry. 2005; 46: 401 408.

Shattuck PT, Durkin M, Maenner M, et al. Timing of identification among children with an autism spectrum disorder: findings from a population-based surveillance study. Journal of the American Academy of Child and Adolescent Psychiatry. 2009; May;48(5):474-483.

Shattuck PT, Narendorf SC, Cooper B, et al. Postsecondary education and employment among youth with an Autism Spectrum Disorder. Pediatrics. 2012; 129: 1042-1049.

Shattuck PT, Wagner M, Narendorf S, et al. Post-high school service use among young adults with an autism spectrum disorder. Archives of Pediatrics & Adolescent Medicine. 2011; 165(2): 141-146.

Taylor JL, and Seltzer MM. Changes in the autism phenotype during the transition to adulthood. Journal of Autism and Developmental Disorders. 2010; 40: 1431-1446.

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 approximately $10,000,000 in FY 2014 to fund 10-18 grants in response to this FOA and the companion announcements.
Award Budget	Direct costs are limited to $450,000 over an R34 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 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.

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 (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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, 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:

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7144, MSC 9631
Bethesda, MD 20892-9631
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-1638
FAX: 301-443-4045
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required 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.

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.

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:

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, 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 achieving program goals for advancing autism research. To achieve the 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 at: http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_data_sharing_language_fin.pdf .

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.

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.

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 by the Center for Scientific Review and for responsiveness to this announcement by NIMH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

The NIMH will hold a pre-application webinar on all three ServASD RFAs (RFA-MH-14-100, RFA-MH-14-101, RFA-MH-14-102) on Wednesday, July 17, from 1:00 2:30 p.m. (EDT), to which all prospective applicants are invited. This is a technical assistance webinar conducted by NIMH staff to explain the goals and objectives of these initiatives and answer questions from attendees. Participation in the webinar is neither required nor necessary for a successful application. Potential applicants who wish to participate should send an e-mail to [email protected] with ServASD RFA Webinar in the subject line no later than 5:00 p.m. (EDT), July 15, 2013, in order to register and obtain the information needed to join the TA session. Potential applicants are encouraged to submit their questions or comments to [email protected] in advance of the call.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

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.

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? Does the intervention to be developed have the potential to significantly improve health, behavioral and functional outcomes for transition age youth with ASD? Does the intervention hold promise in terms of broad reach across subgroups of youth on the autism spectrum and reduction of disparities in receipt of service?

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 proposed developmental work enhance the probability of success in a subsequent R01? Will the pilot work lead to an intervention engineered for rapid adoption and broad implementation in community settings should it prove effective? Does the intervention involve coordination among relevant providers of medical, mental health, education, employment, vocational, and social services, State programs, third party payers, families, etc., as appropriate? Does it hold promise in achieving transition into the adult system without disruptions in services and related adverse outcomes?

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?

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.

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

Not Applicable

Renewals

Not Applicable

Revisions

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.

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) 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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Denise Juliano-Bult, M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

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.

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.