Expired RFA-MH-07-051: Refining and Testing Mental Health Interventions and Services for Youth with Mental Illness who are Transitioning to Adulthood (R34)

Department of Health
and Human Services (HHS)

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EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) ( http://www.nih.gov)

Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

Title: Refining and Testing Mental Health Interventions and Services for Youth with Mental Illness who are Transitioning to Adulthood (R34)

Announcement Type
New

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-MH-07-051

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release/Posted Date: September 11, 2006
Opening Date: September 27, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 27, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Receipt Date(s): November 28, 2006
Peer Review Date(s): March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: November 29, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) solicits research aimed at refining and testing innovative interventions and service delivery models for youth with severe mental illnesses (e.g., youth with disorders that are severe, chronic, and/or significantly impairing; youth for whom treatment is complicated by the need to address comorbid psychiatric and/or substance use disorders and/or HIV/AIDS) who are transitioning to adulthood. Care for individuals in this age range is complicated by the unique developmental context; the multi-problem nature of behavioral health conditions; the lack of evidence-based interventions and services adapted for this age group; and various discontinuities in service systems and health care financing. Responsive applications will propose research to address gaps in available intervention and service delivery strategies for this age group.
This FOA will utilize the NIMH R34 award mechanism (http://grants1.nih.gov/grants/guide/pa-files/PAR-06-248.html) and runs in parallel with an FOA of identical scientific scope, RFA-MH-07-050, that solicits applications under the R01 grant mechanism.
The NIMH intends to commit approximately $1.1 million in total costs in FY 2007 to fund approximately three grants in response to this FOA and RFA-MH-07-050
Budget and Project Period: The total project period for an application submitted in response to this funding opportunity may not exceed three years. Direct costs are limited to $450,000 over an R34 three-year period, with no more than $225,000 in direct costs allowed in any single year.
Eligible Organizations: For-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.
Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.
Applicants may submit more than one application, provided each application is scientifically distinct.
See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:
- http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (MS Word)
- http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf (PDF)
For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of this Funding Opportunity Announcement (FOA) is to solicit research aimed at refining and testing innovative interventions and service delivery models for youth transitioning to adulthood (herein conceptualized as about 16 to 24 years old, to broadly encompass the transition process and accommodate individual differences in timing). The specific focus is on youth with severe mental illness (e.g., youth with disorders that are severe, chronic, and/or significantly impairing; youth for whom treatment is complicated by the need to address comorbid psychiatric and/or substance use disorders and/or HIV/AIDS). As detailed below, care for individuals in this age range is complicated by the unique developmental context; the multi-problem nature of behavioral health conditions; the lack of evidence-based interventions and services adapted for this age group; and various discontinuities in service systems and health care financing. Left untreated, mental health disorders and related impairment during this critical period is associated with trajectories that may lead to negative outcomes, including high rates of chronicity or relapse, disrupted parental custody, hospitalization, incarceration, homelessness and poor community functioning. This FOA is intended to solicit research that addresses gaps in available intervention and service delivery strategies in order to ultimately enhance availability of and access to appropriate care for youth with severe mental illness who are in transition to adulthood.

Developmental considerations and the nature and course of mental health conditions have potentially significant implications for the development and testing of appropriate interventions and service delivery models for youth in this age range. Developmentally, this is a period characterized by expectations for autonomy and increased self-reliance. Accordingly, many young people begin the transition from their parents home into more independent living situations. At the same time, post-secondary education, including college or vocational training, and/or entry into the workforce represent new challenges. Socially, this period is marked by changes in the nature of peer relationships, the emergence of romantic relationships, and role-changes (e.g., parenting roles). Evidence suggests that youth with emotional and behavioral difficulties are often delayed in their psychosocial development, and therefore may not be optimally equipped for the complexities of transition to young adulthood. Consequently, functional impairment associated with mental health problems and disorders at this critical phase of transition can affect the individual’s transition to independent living as well as educational, employment/vocational, and interpersonal outcomes and achievement.

Clinical care for this age group is often complicated by co-occurring problems including high rates of psychiatric comorbidities and substance abuse problems/disorders, histories of abuse, and elevated rates of suicidal and other high risk behaviors. Furthermore, this period heralds the onset of much severe mental illness, including the emergence of psychotic disorders and bipolar disorder. Longitudinal studies of the rates and course of mental health disorders among youth suggest that mental disorders and related impairment during this critical period are associated with a host of negative outcomes, including high rates of chronicity/relapse, hospitalization, incarceration, disruptions in parental custody, homelessness, and interruptions in educational or vocational activities.

Several key discontinuities in mental health care pose particular challenges to provision and coordination of appropriate care for those in this age range. A number of evidence-based treatments (EBTs) have been developed and tested for use with either younger children or with adults. However, few interventions meet commonly used criteria for well established treatments for this age group. Interventions that specifically address the context of transition to adulthood are conspicuously lacking; for example, few interventions explicitly address autonomy issues during this period and the implications for the transfer of responsibility for managing the youth’s illness from parent to young adult patient. Likewise, few existing interventions are informed by the developmental psychopathology literature and longitudinal studies regarding the course and typical sequencing of disorders in during this period. Little is currently known about the special issues related to effectively engaging and sustaining this age group in treatment and services. In addition, the utility of existing interventions for remediating functional impairment and for improving the life course of youths as they move from adolescence to adulthood also has received very limited attention in the interventions literature. Typical disorder-specific evidence-based treatments and acute care models of service delivery are often inadequate for achieving optimal outcomes and functioning for characteristically multi-problem youth in this age range.

Gaps in access to services further complicate care. The venue for mental health services shifts during this period, with schools serving as the de facto service site for many younger children, while adults must seek out care through mental health specialty, primary care or work-site settings. In fact, youth who do not receive special education services (or those who have dropped out of school altogether) and those who do not receive services through the foster care system often have extremely restricted access to mental health services. Data suggest that rates of service utilization precipitously drop as children age-out of eligibility for school-based services. The termination of eligibility and availability of school-based services is particularly problematic for those with disorders that require intensive services that are principally delivered through educational settings, such as youth with autism spectrum disorders.

Disruptions in health care financing streams also complicate coordination and continuity of care, for both the publicly and privately insured. Depending on the state, publicly funded child mental health services end when youth reach the age of 18 to 22 years. In most localities, different criteria are used to define eligibility for publicly-funded mental health services across youth and adult systems, with more broad criteria used in the child/adolescent system. Similarly, coverage under parents private health care insurance usually ends by age 23 or when the youth is no longer a full-time student.

As is the case with special health needs in general, transition planning for youth with mental health problems and disorders receives little or no explicit attention, which limits availability, coordination, and continuity of care during this period. Transition planning to ensure continuity of care is an objective of the US DHHS Healthy People 2010 (http://www.healthypeople.gov/) and is recommended in the president’s New Freedom Initiative (http://www.mentalhealthcommission.gov/) as a means to facilitate access to care and community integration for people with disabilities. The importance of health care transitions for young adults with special health needs has also been acknowledged in a consensus statement issued by the American Academy of Pediatrics, American Academy of Family Physicians, and American College of Physicians-American Society of Internal Medicine. Yet, results from the National Survey of Children with Special Health Care Needs (http://mchb.hrsa.gov/chscn/) commissioned by the Maternal and Child Health Bureau suggest that overall rates of transition planning are low, and rates are particularly low for racial and ethnic minorities.

This FOA is intended to solicit research that addresses gaps in available intervention and service delivery strategies for youth in transition to adulthood. Examples of research strategies and topics might include, but are not limited to, the following:

Developing and testing novel interventions based on theories of developmental psychopathology in order to broaden the selection of effective interventions for the diverse youth in this period of transition.
Examining the use of novel or existing interventions and service delivery models for underserved youth (e.g., diverse youth in inter-city or rural settings) for improving clinical and functional outcomes and for reducing disparities in service access and utilization.
Examining the effectiveness of existing treatments for addressing mental disorders and co-existing conditions (substance use, HIV/AIDS and/or other medical conditions), especially in community settings such as community mental health centers, juvenile justice systems, homeless youth.
Developing strategies to facilitate identification and treatment of transition-aged individuals in various non-mental health settings to improve mental health and with the explicit goal to interrupt negative trajectories (e.g., to address mental health needs and prevent transition to adult criminal justice settings among youth in juvenile justice settings; to treat psychiatric disorders, reduce victimization, and improve housing outcomes among homeless youth).
Exploring the utility of combining and/or sequencing evidence based treatment interventions (e.g., effective medication algorithms, functional family therapy) and established secondary prevention strategies to comprehensively address common trajectories (e.g., escalating rates of substance use/abuse problems, suicidality and other high risk behaviors) among youth with mental disorders.
Optimizing pharmacotherapy (e.g., refining strategies to enhance adherence, to facilitate transfer of responsibility from parent/guardian to young patient, to improve surveillance of adverse effects associated with long-term medication regimens) for transition-age youth.
Assessing the degree to which mental health services delivered in specialty and non-specialty settings facilitate cross-setting improvements in functioning (e.g., degree to which education-based programs for youth with autism facilitate sustained cross-setting functioning in work/vocational and other settings).
Systematically examining the effectiveness of existing service delivery models and common practices (e.g., aftercare programs, supportive employment, educational and housing support models) for improving mental health and functional outcomes among youth.
Examining the impact of embedding evidence-based treatment interventions (e.g., cognitive behavioral strategies) within effective service delivery models (e.g., intensive case management, assertive community treatment) in effectiveness trials.
Exploring service utilization data to identify factors that impede or facilitate coordination and continuity of needed services.
Refining and testing supportive services models aimed at facilitating coordination of services and continuity of care during the period of transition from youth to adulthood (e.g., as youth age-out of school-based services or foster care services).
Adapting strategies for facilitating adherence and continuity of care that have been successful with other conditions (e.g., chronic medical illnesses) for use with youth with mental disorders.
Developing strategies and interventions for adolescents who are utilizing metal health services and who are also at high risk for acquiring STD s/HIV to incorporate STD/HIV prevention in the delivery models for transition to adult care.
Developing strategies, interventions, and service delivery models for transition-age adolescents with both HIV-infection and mental disorders to ensure continuity of care and improve clinical and STD/HIV secondary prevention outcomes.
Exploring provider and systems-level strategies that will facilitate transition planning and help ensure coordinated, continuous care as individuals transition from child/adolescent- to adult- 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).

This FOA is not intended to solicit research that documents the nature/rate of problems among transition-age youth or research that involves age-appropriate adaptations of disorder-specific interventions. The explicit goal is interventions and services research targeting youth with serious mental illness (e.g., youth with disorders that are severe, chronic, and/or significantly impairing; youth for whom treatment is complicated by the need to address comorbid psychiatric and/or substance use disorders and/or HIV/AIDS). Responsive applications should also incorporate outcomes relevant to multiple stakeholder perspectives, including youth, their families, payers, and policy makers (i.e., not only symptom reduction or change in diagnostic status, but also mental- and general- health service utilization, costs, and family/interpersonal-, school-, work-, and community functioning/achievement).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIMH R34 award mechanism ( http://grants.nih.gov/grants/guide/pa-files/PAR-06-248.html. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

Applications from foreign (non-U.S.) institutions submitted via Grants.gov using the SF 424 (R&R): Follow the Research & Related Budget Component Instructions. Complete and submit the RESEARCH & RELATED BUDGET forms. Do not complete or submit the PHS 398 Modular Budget component.

2. Funds Available

The NIMH intends to commit approximately $1.1 million in total costs in FY 2007 to fund approximately 3-5 grants in response to this RFA and RFA MH-07-050. The total project period for an application submitted in response to an R34 funding opportunity may not exceed three years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Units of State government
Units of Local government
Eligible agencies of the Federal government
Domestic Institutions/organizations
Foreign Institutions/organizations
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

Grants.gov (http://www.grants.gov/GetStarted) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (ARO/SO) or their designee who is already registered in the Commons.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget *

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R34 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.) *Applications from foreign (non-U.S.) institutions submitted via Grants.gov using the SF 424 (R&R): Follow the Research & Related Budget Component Instructions. Complete and submit the RESEARCH & RELATED BUDGET forms. Do not complete or submit the PHS 398 Modular Budget component.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component). See NOT-OD-06-096.
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.
Additional information regarding foreign grants is available in the NIH Grants Policy Statement.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt and Review and Anticipated Start Dates
Opening Date: September 27, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 27, 2006
Application Receipt Date(s): November 28, 2006
Peer Review Date(s): March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research.
Name, address, and telephone number of the PD/PI.
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Joel Sherrill, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7145, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-2477
FAX: (301) 443-4045
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

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

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
If the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix Materials

The following materials may be included in the Appendix:

Up toten publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication.
Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH PubMed Central (PMC) submission identification number. Do not include the entire article.
Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.
Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Plan for Sharing Research Data

N/A

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory Mental Health Council.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important scientific health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., Funding Restrictions.

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

NIMH Policy for the Recruitment of Participants in Clinical Research: On June 1, 2005, NIMH instituted a new policy to monitor the recruitment of participants in NIMH-sponsored clinical research studies that expect to enroll 150 or more human subjects. The purpose of this policy is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research (http://www.nimh.nih.gov/researchfunding/nimhrecruitmentpolicy.cfm).

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

For inquiries regarding interventions research:

Joel Sherrill, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7145, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-2477
Fax: (301) 443-4045
Email: [email protected]

For inquiries regarding mental health services research:

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7137, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-1638
Fax: (301) 443-4045
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3534
Email: [email protected]

3. Financial or Grants Management Contacts:

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Fax: (301) 443-6885
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices