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 Disorders across the Lifespan (ServASD):  Pilot Studies of Services Strategies for Adults with ASD (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-14-102

Companion Funding Opportunity

RFA-MH-14-100, R01 Collaborative Research Project Grant
RFA-MH-14-101, 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

This Funding Opportunity Announcement (FOA) will support pilot studies to develop and test service strategies that optimize the independence and functioning of adults with autism spectrum disorders (ASD).  This FOA invites preliminary studies to develop adult ASD service strategies that address areas of employment and training, social relationships, physical and mental health, and independent functioning including community housing and safety, alone or in combination.  The ultimate goal of this activity is to improve behavioral, functional and health outcomes in adults with ASD.  In targeting adults, this FOA is focused on individuals who have completed transition out of services delivered via the child and adolescent service system and the primary education system. 

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-14-101, which targets services strategies to enable transition age youth to transition to the adult service system without loss of services or functioning.

Key Dates
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.

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 FOAs, RFA-MH-14-100 (R01), Research on Early Identification and Linkage to Services and RFA-MH-14-101 (R34), Pilot Research on Services for Transition Age Youth, is to stimulate research that develops and tests the effectiveness of service system interventions to improve functional and health outcomes for people with autism spectrum disorder (ASD) at 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 and, 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, for adults with ASD, there is little empirical evidence to establish the effectiveness of services, and the extant research does not adequately address the range of service needs of adults with ASD and the challenges in coordinating across service sectors.  Strategies to identify and provide services for previously undiagnosed adults with ASDs are also needed.

Service Needs of Adults with ASD

There is a growing need for research on how services and supports for adults with ASD can be structured so as to lead to optimal behavioral and functional outcomes.  In addition to the impact of people diagnosed as children aging into adulthood, there is an increase in previously undiagnosed ASD being identified in adulthood, thus adding to demand for adult services (Murphy et al, 2011). The 2012 Strategic Plan of the Interagency Autism Coordinating Committee has framed research objectives for adult services in the areas of needs assessment, coordination across service systems, and provision of lifelong community supports for individuals and families.  Within the framework of the 2012 Strategic Plan, NIMH issues this FOA to support pilot studies of services strategies to optimize the independence and functioning of adults with ASD across the heterogeneity of the disorder. 

Many adults with ASD, including those whose IQs are within normal range, are significantly disadvantaged in the areas of employment, social relationships, community housing supports, physical and mental health, and independent functioning. While the course of symptoms varies over developmental trajectories, continued impairment, particularly in social communication, persists into adulthood. Adding to the challenge of adult service provision is the heterogeneity of this population, including ongoing differences in brain maturation that extend into and continue to change through adulthood (Howlin and Moss, 2012). Further, individuals with ASD face special challenges after exiting high school, when they often face new functional demands and have fewer services available to them. 

In addition to addressing the deficits directly associated with ASD, there is a need for the identification and management of the commonly co-occurring psychiatric conditions, such as depression or anxiety disorder and ADHD. Adults with ASD are also at greater risk for untreated medical comorbidities (Bradley, et al, 2004, Murphy, et al, 2011, Shattuck, 2012).  A comprehensive services approach must also include strategies to improve employment outcomes, as most adults with ASD are chronically unemployed or underemployed at relatively high rates.  Further, as persons with high functioning ASD have significant rates of contact with the criminal justice system (Lerner, et al, 2012), strategies for reducing behaviors that lead to police contact and for improving the outcomes of police contacts when they happen are also needed.  

Even in adulthood, family often remains a source of support, providing housing, case management and a venue for continuing development of communication and social skills for people with ASD.  Maximizing and supporting such contributions must be factored into the development of service strategies.  A particular emphasis is needed on care coordination and establishing the effectiveness of support for navigating multi-sector systems of care.  The dearth of formal adult services suggests a need to increase a family’s capacity to find or effectively advocate for services and to create informal supports and services for adults with ASD.

Specific Areas of Research Interest

This FOA invites pilot studies in preparation for full scale tests of the effectiveness of service delivery or coordination strategies for adults with ASD across the heterogeneity of the disorder.  All proposed interventions should include strategies to reduce or eliminate racial, ethnic, gender or socio-economic disparities in the identification and treatment of adults with ASD.  The R34 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 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.

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

Successful applications will propose a service intervention that can generalize 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 adults on the autism spectrum; (b) improved health, behavioral and functional outcomes for adults with ASD; and (c) reduction of disparities in linkage to and receipt of services.  Applications are encouraged to briefly describe the specific R01 to which the proposed study is intended to lead. Wherever possible, applicants should use efficient research approaches, including use of existing platforms for subject recruitment, data collection, and analysis.   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 (CTSAs) and the Mental Health Research Network (MHRN) and three networks funded by the Health Resources and Services Administration:  Autism Intervention Research Network on Behavioral Health (AIR-B), Autism Intervention Research Network on Physical Health (AIR-P), and Developmental and Behavioral Pediatrics Research Network (DBP-RN).

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

References

Bradley EA, Summers JA, Wood HL, et al. Comparing rates of psychiatric and behavior disorders in adolescents and young adults with severe intellectual disability with and without autism. Journal of  Autism and Developmental  Disorders. 2004; Apr;34(2): 151-61.

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.

Gerhardt P, Lanier I. Addressing the needs of adolescents and adults with autism: a crisis on the horizon.  Journal of Contemporary Psychotherapy. 2011; Mar;41(1):37-45.

Howlin P, Moss P. Adults with autism spectrum disorders. Canadian Journal of Psychiatry. 2012 May; 57(5):275-83.

Interagency Autism Coordinating Committee.  2012 IACC strategic plan for autism spectrum disorder research.  Washington (DC): US Department of Health and Human Services, 2012.

Lerner MD, Haque OS, Northrup EC, et al. Emerging perspectives on adolescents and young adults with high-functioning autism spectrum disorders, violence and criminal law. Journal of the American Academy of Psychiatry and the Law. 2012;40(2):177-90.

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.

Murphy DGM, Beecham J, Craig M, et al. Autism in adults. New biological findings and their translational implications to the cost of clinical services.  Brain Research 1380 (2011) 22-33.

Shattuck P, Roux AM, Hudson LE, et al. Services for adults with an autism spectrum disorder. Canadian Journal of Psychiatry. 2012 May; 57(5): 284-91.

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.

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 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 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 three years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.

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.

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.

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:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

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: ServASD@mail.nih.gov  

Page Limitations

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

Required and Optional Components

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.

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.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Letter

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:

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 program goals for advancing autism research.  To achieve program goals, data sharing is expected and NDAR will be involved to facilitate sharing activities.  NDAR will function as a data repository for all funded projects.  Central clinical coordination and local data management for data cleaning and entry and bio-statistical consulting will be the responsibility of the grantee(s). For more information on NDAR, please visit http://ndar.nih.gov/ndarpublicweb/.  The NDAR terms and conditions can be found 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.

3. Submission Dates and Times

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.

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 the criteria outlined in 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 NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Pre-Application Webinar

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 ServASD@mail.nih.gov 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 session.  Potential applicants are encouraged to submit their questions or comments to ServASD@mail.nih.gov  in advance of the call. 

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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? Does the intervention to be developed have the potential to significantly improve health, behavioral and functional outcomes for adults with ASD?  Does the intervention hold promise for broad reach across subgroups of adults 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 improving receipt of services and improvement in behavior and functioning among adults with ASD?    

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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:

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the 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. 

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Denise Juliano-Bult, M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: ServASD@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 Parts 74 and 92.


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