Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	Improving Health and Reducing Premature Mortality in People with Severe Mental Illness (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	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-14-060
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242
Funding Opportunity Purpose	People with severe mental illness (SMI) die from the same causes as those in the general population, e.g., heart disease, diabetes, cancer, stroke, and pulmonary disease. However, these diseases are more common in people with SMI and lead to earlier death. The modifiable health risk factors that contribute to these diseases smoking, obesity, hypertension, metabolic disorder, substance use, low physical activity, poor fitness and diet are also more common and have an earlier onset in people with SMI. Side effects of psychiatric medications, which may include weight gain and metabolic disorder, add to these health risks. Effective interventions to reduce these common modifiable health risk factors exist for the general population, however, they are generally unavailable to people with SMI and evidence is sparse on how to bring them to this population. This FOA will support R01 grants of up to five years for rigorous effectiveness testing of innovative services interventions designed to reduce the prevalence and magnitude of common modifiable health risk factors related to shortened lifespan in adults with severe mental illness (SMI), as well as in children and youth with serious emotional disturbances (SED).

Posted Date	March 12, 2013
Open Date (Earliest Submission Date)	October 7, 2013
Letter of Intent Due Date(s)	October 7, 2013
Application Due Date(s)	November 7, 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 2014
Advisory Council Review	May 2014
Earliest Start Date	July 2014
Expiration Date	November 8, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

People with severe mental illness (SMI) die from the same causes as those in the general population, e.g., heart disease, diabetes, cancer, stroke, and pulmonary disease. However, these diseases are more common in people with SMI and lead to earlier death. For example, adults with psychotic disorders die, on average, 11 years earlier than adults with no mental disorder, most often from these co-morbid medical conditions (Druss, Zhao, Von Esenwein, Morrato & Marcus, 2011). The modifiable health risk factors that contribute to these diseases smoking, obesity, hypertension, metabolic disorder, low physical activity, substance use, poor fitness and diet are also more common and have an earlier onset in people with SMI (SAMHSA, 2008-2010). Two-thirds or more of adults with SMI smoke (Goff, Sullivan, McEvoy, Meyer, Nasrallah, Daumit,et al., 2005); over 40% are obese, 60% for women (Allison, Fontaine, Heo, Chandler, Capelleri, Infante, et al., 1999; McElroy, 2002); and metabolic syndrome is highly prevalent, especially in women (McEvoy, Meyer, Goff, Nasrallah, Davis, Sullivan, et al., 2005). Iatrogenic effects of psychiatric medications, which may include weight gain and metabolic disorder, add to these health risks (Allison, Mentore, Heo, et al., 1999). The 11.4 million adults with SMI in the U.S. are disproportionately affected by these modifiable health risk factors, and their low rates of prevention, detection, and treatment result in substantial disease burden and premature mortality (Druss et al., 2011; Nasrallah, Meyer, Goff, et al., 2006; SAMHSA, 2008-2010). Effective interventions to reduce these health risk factors exist for the general population, but they are generally unavailable to people with SMI. Furthermore, the impact of these interventions and the degree of adaptation needed for effectiveness in people with SMI, who may experience cognitive impairment, motivational deficits, challenges in functioning, social isolation, poverty, and limited access to healthcare, remain unknown.

The initial occurrence and early progression of modifiable health risk factors associated with premature mortality are poorly understood, but at least some of the increased risk that compromises health and longevity begins to emerge prior to adulthood. Children and adolescents may be especially vulnerable to the adverse metabolic effects of psychiatric medications given their developing bodies and brains (De Hert, Detraux, van Winkel, et al., 2012). Moreover, the number of children and adolescents prescribed psychiatric medications for both off-label and FDA-approved uses is growing, which may increase the number of young people developing modifiable health risk factors associated with premature mortality as well as lead to earlier onset of these risk factors (Comer, Olfson & Mojtabai, 2010).

In September of 2012, NIMH hosted a meeting, Research to Improve Health and Longevity of People with Severe Mental Illness, which brought together leading researchers, state administrators who have implemented programs to reduce modifiable health risk factors in people with SMI, advocates for this population, policy leaders and representatives from other NIH institutes and federal agencies. Key research priorities that emerged from this two-day meeting include the following:

• Studies targeting medical comorbidities, tobacco cessation, prevention of diabetes and cardiovascular disease, and reduction in psychotropic polypharmacy as the major intervention targets to reduce premature mortality;
• Studies focusing on achieving clinically (not just statistically) significant reductions in health risk factors;
• Studies that leverage existing natural experiments by testing the effectiveness of promising services interventions already implemented at state and local levels;
• Studies integrating a combination of interventions that are often harder to sustain but produce more robust effects compared to the modest effects of single component interventions;
• Studies that improve our understanding of how best to integrate multiple treatment components; and
• Studies to develop and test strategies that reduce or eliminate racial, ethnic or gender disparities in the development of medical comorbidities, or in the receipt of or response to interventions addressing comorbidities among people with SMI.

The goal of this Funding Opportunity Announcement (FOA) is to support research to test the effectiveness of services interventions that specifically target adults with SMI and aim to reduce the prevalence and magnitude of common modifiable health risk factors that contribute to premature mortality in this population, using the most rigorous methods possible. This FOA is also intended to support research for children and youth with serious emotional disturbances (SED) in order to target common modifiable health risk factors at an early stage in the developmental process. (For purposes of this FOA, NIMH defines severe mental illness or SMI and serious emotional disturbance or SED as a diagnosable psychiatric disorder that results in functional impairment which substantially interferes with or limits major life activities. The criteria for inclusion as an SMI or SED relate to the severity of the psychiatric disorder causing significant impairment rather than to a specific diagnostic category, per se.)

This initiative will support research that builds on strategies proven effective in reducing modifiable health risk factors in the general population. Applications that develop and test service interventions for large-scale delivery of these effective strategies to people with SMI or SED are encouraged. To that end, critical aspects of the intervention and delivery strategy should be designed so as to support broad dissemination and implementation of the approach should it prove effective. The research generated should address at least one of the following questions:

1. How can strategies proven effective for reducing common modifiable health risk factors in the general population be adapted with the goal of achieving equivalent effectiveness for people with SMI or SED?

2. How can capacity to deliver needed health risk prevention and reduction be significantly improved to reach the largest number of people with SMI or SED?

Examples of research questions considered responsive to this FOA include, but are not limited to, the following:

• How can a diabetes prevention program, effective in the general population, produce the same health benefits in people with SMI or SED?
• How can medication management approaches minimize the adverse health consequences of antipsychotic medication while maintaining optimal psychiatric and functional outcomes in adults with SMI? In children and youth with SED?
• How can community mental health centers efficiently incorporate clinical decision support tools to maximize screening and engagement in care for modifiable health risk factors associated with cardiovascular disease?
• Can the targeted use of social media support smoking cessation in adults with SMI?
• What strategies enable non-health care settings to serve as effective platforms for detection of common modifiable health risk factors and linkage to treatment?
• Can a smartphone application targeting fitness, diet and obesity produce clinically significant outcomes in this population?
• What strategies can reduce or eliminate racial, ethnic or gender disparities among people with SMI in the development of medical comorbidities or the receipt of or response to treatment for these comorbidities?

In addition, NIMH encourages applicants to also consider factors influencing implementation of the services intervention that is the focus of the research project. Services interventions with health promotion, lifestyle change and self-management components for people with SMI are encouraged, as well as those integrating intervention components in order to target multiple health risk factors and/or increase the magnitude of treatment effects. Examples of services interventions for people with SMI or SED might include, but are not limited to, those involving one or more of the following:

• Diabetes prevention
• Cardiovascular disease prevention
• Obesity prevention
• Fitness and diet improvement
• Psychotropic polypharmacy reduction
• Tobacco cessation
• Antipsychotic medication management that maximizes optimal psychiatric and functional outcomes while minimizing side effects and adverse health consequences

The services intervention must specifically target people with SMI or SED and modifiable health risk factors that are the primary causes of premature mortality in this population. Ideally, the services intervention will have the following features:

• has demonstrated clinical effectiveness of the intervention's core components in the general population (although adaption may be needed for equivalent effectiveness in people with SMI or SED);
• has relevance to the life circumstances of people with SMI or SED;
• will be conducted in a community-based setting that serves as a platform to engage this population (either within or outside of traditional healthcare settings);
• has the potential to produce clinically (not just statistically) significant health improvement and reduction in common modifiable health risk factors associated with early mortality in people with SMI;
• will target all people with SMI or SED in a given setting, community or care delivery system;
• has a high likelihood for real-world feasibility in terms of required resources, staffing, training, and patient acceptability;
• has strong potential to be expanded easily to many settings, so as to reach a large portion of people with SMI or SED at risk, should the services intervention prove clinically effective with this population.

A variety of rigorous methodological approaches are possible for testing the impact of the services intervention. These approaches include randomized controlled trials, quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed effectiveness study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity. The applicant should explain how the selected research methods minimize confounds that may limit the ability to infer causality. Regardless of the proposed methods, the project should include assessment of clinically significant patient-level outcomes that represent objective indicators of health improvement, e.g., improved glycemic levels, improved lipid levels, lowered cholesterol levels, healthier body mass index, and lowered blood pressure.

References

Allison DB, Fontaine KR, Heo M, et al (1999) The distribution of body mass index among individuals with and without schizophrenia. Journal of Clinical Psychiatry, 60(4):215-220.

Allison DB, Mentore JL, Heo M, Chandler LP, Capelleri JC, Infante, MC, & Weiden PJ (1999) Antipsychotic-induced weight gain: A comprehensive research synthesis. American Journal of Psychiatry, 156(11):1686-1696.

Comer JS, Olfson M, Mojtabai R (2010) National trends in child and adolescent psychotropic polypharmacy in office-based practice, 1996-2007. Journal of the American Academy of Child and Adolescent Psychiatry, 49: 1001-1010.

Compton MT, Daumit GL, Druss BG (2006) Cigarette smoking and overweight/obesity among individuals with serious mental illnesses: A preventive perspective. Harvard Review Psychiatry, 14(4):212-22.

De Hert M, Detraux J, van Winkel R, Yu W, Correll CU (2012) Metabolic and cardiovascular adverse effects associated with antipsychotic drugs. Nature Reviews Endocrinology, 8 (Feb): 114-126.

Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC (2011) Understanding excess mortality in persons with mental illness: 17-year follow up of a nationally representative US survey. Med Care, 49(6):599-604.

Goff DC, Sullivan LM, McEvoy JP, Meyer JM, Nasrallah HA, Daumit GL, et al (2005) A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophrenia Research, 80(1):45-53.

McElroy SL (2002) Correlates of overweight and obesity in 644 patients with bipolar disorder. Journal of Clinical Psychiatry, 63:207-213.

McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, et al (2005) Prevalence of the metabolic syndrome in patients with schizophrenia: Baseline results from the (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophrenia Research, 80(1):19-32.

Nasrallah HA, Meyer JM, Goff DC, et al (2006) Low rates of treatment for hypertension, dyslipidemia and diabetes in schizophrenia: Data from the CATIE schizophrenia trial sample at baseline. Schizophrenia Research, 86(1-3):15-22.

SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2008-2010.

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 $2,000,000 in FY 2014 to fund five to eight awards in response to this FOA.
Award Budget	Budgets may not exceed $499,999 in direct costs per year, which includes all consortium direct and F&A costs.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed five years.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

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

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

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

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

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

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

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

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

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

The letter of intent should be sent to:

Susan T. Azrin, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7145, MSC 9631
Rockville, MD 20892-9631
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-3267
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

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

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

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

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is evidence provided that supports the potential of the proposed services intervention to produce clinically meaningful (versus statistically significant) reductions in common modifiable health risk factors associated with premature mortality in the target population of people with SMI or SED? Is the proposed services intervention designed to support broad dissemination and implementation in real-world settings should it prove effective? Does the application address a critical question related to (1) adapting evidence-based health risk reduction interventions to achieve clinically significant effectiveness in people with for SMI or SED, or (2) increasing capacity to deliver health risk reduction interventions to populations with SMI or SED? If the services intervention targets a population with multiple health risk factors, does it integrate the multiple components of the intervention?

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? Do the qualifications of the PD/PI and other senior investigators include expertise in one or more of the following areas:

• Implementing health promotion or risk reduction programs for people with SMI or SED;
• Conducting large-scale practical tests of health promotion or risk reduction services interventions in real-world settings;
• Recruiting and retaining people with SMI or SED in large-scale studies; and
• Assessing common modifiable health risk factors?

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? Does the proposed services intervention use novel means to increase the intervention's effectiveness, efficiency or reach to people with SMI or SED?

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? 

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? Do the chosen outcome variables represent relevant and objective measures of health improvement, such as improved glycemic levels, improved lipid levels, lowered cholesterol levels, healthier body mass index, and lowered blood pressure? Where applicable, does the application adequately address racial, ethnic, or gender disparities in the receipt of or response to health risk reduction interventions among people with SMI or SED? Has the applicant explained how the selected research methods minimize confounds that may limit the ability to infer causality?

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? Does the proposed services intervention capitalize on a real-world setting that is already engaging people with SMI or SED?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

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

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

Susan T. Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3267
Email: [email protected]

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

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

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.