Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	Leveraging Existing Natural Experiments to Advance the Health of People with Severe Mental Illness (R24)
Activity Code	R24 Resource-Related Research Projects
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-MH-13-140
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. Iatrogenic 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, these interventions are generally unavailable to people with SMI and evidence is sparse on how to bring them to this population. Many state and local health authorities have implemented innovative services interventions to reduce the identified health risk factors and premature mortality in people with SMI, though their effectiveness for this population and the degree of adaptation needed for effectiveness remain unknown. The National Institute of Mental Health (NIMH) seeks to leverage these existing natural experiments by building research capacity for subsequent rigorous testing of services interventions already implemented at state and local levels for adults, youth or children. This FOA will support one-year R24 grants for research planning activities to develop the infrastructure needed to enable subsequent testing of existing innovative services interventions that aim to reduce the prevalence and magnitude of common modifiable health risk factors related to shortened lifespan in people with SMI. See the related Notice of Intent to Publish a Funding Opportunity Announcement for Improving Health and Reducing Premature Mortality in People with Severe Mental Illness (R01), NOT-MH-13-010.

Posted Date	January 7, 2013
Letter of Intent Due Date(s)	February 11, 2013
Application Due Date(s)	March 11, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June 2013
Advisory Council Review	August 2013
Earliest Start Date	September 1, 2013
Expiration Date	March 12, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Part 1. Overview Information
Part 2. Full Text of 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.

Most SMI begins in childhood or adolescence. 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, that 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 which 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;
• Studies that improve our understanding of the heterogeneity of outcomes when approach is held constant;
• Studies that counter the systematic exclusion of people with SMI from clinical trials for medical conditions by supplementing trials to add samples of people with SMI; and
• Studies that increase our understanding of race/ethnicity/gender differences in the development of medical comorbidites and response to treatment.

This funding opportunity announcement (FOA) aims to support the development of research infrastructure necessary to systematically test services interventions already in the field that have the potential to produce clinically significant reductions in common modifiable health risk factors associated with early mortality in people with SMI, using the most rigorous methods practical. This FOA is also intended to support research planning activities around services interventions for children and youth with serious emotional disturbances 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.) At the conclusion of the one-year funding period, grantees of this FOA should have the research infrastructure necessary to pursue funding for conduct of a comprehensive study of the services intervention's effectiveness, including assessment of clinically significant patient-level outcomes. A variety of methodological approaches may be appropriate for this testing. See NOT-MH-13-010 - Notice of Intent to Publish a Funding Opportunity Announcement for Improving Health and Reducing Premature Mortality in People with Severe Mental Illness (R01).

Many state and local health authorities have implemented innovative services interventions to reduce common modifiable health risk factors and premature mortality in people with SMI. Examples include interventions for smoking cessation, diabetes prevention, fitness promotion or obesity that target a service delivery system's entire at-risk population of people with SMI. These represent "natural experiments," i.e. interventions already implemented in real-world settings and ripe for systematic testing to determine their effectiveness for people with SMI. However, these services interventions may lack the research infrastructure necessary for rigorous effectiveness testing.

Specific Research Planning Activities

Activities that are appropriate to this FOA might include, but are not limited to the following:

• Establishing and pilot testing feasible data collection and management mechanisms
• Developing and pilot testing assessment protocols
• Establishing and pilot testing outcome measures
• Establishing data use agreements
• Gathering baseline data
• Refining the services intervention that is the focus of this initiative
• Identifying appropriate comparison conditions
• Developing randomization procedures (if applicable)
• Developing participant recruitment and retention procedures
• Developing procedures for the protection of human subjects and data and safety monitoring for a full-scale effectiveness trial
• Developing manuals and other materials and resources needed for a full-scale effectiveness trial

The specific research planning activities proposed will vary depending on the methodological approach anticipated for subsequent effectiveness testing.

Any proposed pilot test activity should be completed within the one-year time period of this FOA and focus on feasibility and/or acceptability of the research methods. Proposed pilot test activities should not aim to assess clinical outcomes or the services intervention's effectiveness.

Research planning activities should include identification of relevant outcome measures that represent objective indicators of health improvement, e.g. improved glycemia 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 PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIMH intends to commit approximately $1,000,000 in FY 2013 to fund three to seven awards in response to this FOA.
Award Budget	Budgets may not exceed $200,000 (direct costs) per year.
Award Project Period	The total project period for an application submitted in response to this FOA may not exceed 12 months.

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 must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

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 PHS 398 Application Guide.

Qualifications of the PD/PI and other senior investigators should include expertise in one or more of the following areas (as demonstrated in their biosketches):

• Implementing health promotion or risk reduction programs for people with SMI;
• 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

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 are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS 398 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.

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 research
• 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]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

NIMH Referral Office
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy

It is not expected that applicants to this FOA will have produced pilot data or completed preliminary studies on the services intervention for people with SMI or SED that is the focus of their application. However, applicants are expected to include in their application a review of the literature relevant to the targeted services intervention and its potential for health improvement in people with SMI or SED.

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 PHS 398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

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.

For this particular announcement, note the following:

This funding opportunity is intended to support a set of research planning activities to enable subsequent effectiveness testing of an existing services intervention that aims to reduce the prevalence and magnitude of common modifiable health risk factors related to premature mortality in people with severe mental illness (SMI), as well as in children and youth with serious emotional disturbances (SED). As such, applicants to this FOA are encouraged to develop a specific set of planning activities, relevant to the targeted services intervention, that will lay the groundwork for a future effectiveness trial.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed set of planning activities target a services intervention that has the potential to produce clinically significant reductions in common modifiable health risk factors for the target population of people with SMI or SED?

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;
• 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? Are novel methods proposed for the systematic measurement of objective indicators of health improvement in real-world research settings?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed set of planning activities? 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 proposed set of planning activities 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? Are the proposed set of planning activities feasible to be completed in the one-year timeframe of the funding opportunity? Will the proposed set of planning activities, if accomplished, build the research capacity necessary for a subsequent large-scale test of the service intervention's effectiveness? Does the proposed set of planning activities include identification of objective indicators of health improvement as primary outcomes for the subsequent practical trial?

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 services intervention that is the target of the planning activities capitalize on a real-world setting that is already engaging people with SMI and 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 planning activities 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 response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and 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.

Not Applicable

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

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

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

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

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

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: [email protected]

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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.