It is critical that applicants follow the Research (R) 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

In 2015, the Centers for Disease Control and Prevention reported that there were more than 44,000 suicide deaths in the United States, which is two and half times the number of homicide deaths in the same year. The annual suicide rate in the U.S. has continued to climb over the past sixteen years and suicide is one of the 10 leading causes of death. Reports of a reduction in men’s longevity due to overdose and suicide deaths have put U.S. mortality data in the spotlight. Compounding the impact of this preventable loss of life, the rate of nonfatal suicide attempts is many times higher than the rate of suicide death and the economic impact of suicidal behaviors has been estimated to exceed more than $40 billion annually in the U.S. Suicide decedents are not unknown to health care settings. A significant proportion of U.S. suicide decedents have accessed health care within the year of their death, with estimates ranging from 30% to 80%, mirroring the broader population access to health care. Approximately one-quarter of suicide decedents had treatment for psychiatric issues prior to their death.

The primary goal of this FOA is to solicit applications that propose to directly inform our understanding of mortality outcomes subsequent to healthcare visits. This effort is consistent with NIMH Strategic Research Objective 4, which calls for strengthening the public health impact of NIMH-supported research. It is consistent with NIDA strategic priorities, including an emphasis on addressing real world complexities of substance use and substance use disorders, such as psychiatric comorbidities (including within the context of overdose deaths), and increasing the public health impact of NIDA supported research (Goal 4). This FOA also speaks to goals in the Prioritized Research Agenda for Suicide Prevention that estimated the number of suicidal individuals who had been seen in boundaried systems (e.g., health care, education, workplaces, incarceration, etc.), who could have been reached by improved detection and intervention, and how many suicide attempts (fatal and nonfatal) could have been prevented. Through that effort, multiple gaps in data linkages were noted. This FOA is also responsive to a 2016 NIH Office of Disease Prevention workshop, Advancing Research to Preventing Youth Suicide, where experts recommended expansion of surveillance of suicide and suicide attempts by linking data from multiple sources (e.g., state all-payer databases, syndromic emergency room data, electronic health records data, health information exchanges, accountable care organizations, research data).

Since 1995 the Joint Commission (JC) has consistently listed suicide among the top 5 sentinel events, i.e., unexpected occurrences involving death or serious physical or psychological injury, taking place in health care settings. The JC issued a Sentinel Alert in February 2016 that includes recommendations for appropriate discharge planning that keeps patients safe. This means that as patients transition to home and/or across care settings, health care services should work to keep patients safe. Of the 1.3 million individuals in the U.S. who reported making a suicide attempt within the past 12 months, about 6% also reported receiving treatment in an outpatient mental health clinic (estimated 206,000 cases). Rates of individuals reporting attempts within the year have also been estimated for those receiving care in other settings that include: those receiving substance use treatment (5%, estimated 122,000 cases); and those having accessed emergency care in the same year (1%, estimated 728,000 cases). Despite the large number of suicide events among persons receiving healthcare, not all states require health care systems to report adverse events that include suicide deaths and attempts, that occur during or following receipt of services. Lack of information about the rate and nature of suicide events within and between care systems hinders efforts to eliminate these adverse events through quality improvement initiatives.

The U.S. military and Veterans Health Administration have reported on suicide mortality outcomes among those seen in their respective health care systems. This information spurred actions in those systems to improve care aimed at preventing suicide. In the absence of U.S. civilian healthcare data linked to mortality outcomes, researchers rely on Canadian and European estimates of mortality risk for civilians seen in health care settings. What is clearly needed to better understand the real burden of suicidal behavior are mortality outcomes for individuals seen in U.S. healthcare settings. Such data might then serve as essential benchmarks for both public and private care providers/insurers who are seeking care improvements to reduce suicide events in their systems. Incentives to support the development of teams with appropriate expertise that can link relevant healthcare data sources with mortality data might serve to both facilitate an empirical understanding of the scope of the issues in this area, as well as the development of novel interventions and/or strategic implementation of existing treatment options. In addition to improving our national knowledge of the burden of suicide, these are essential metrics for both public and private care providers/insurers, who increasingly will be seeking improvements to drive down suicide events in their systems.

Responses received to a recent Request for Information from the NIMH (NOT-MH-16-027) support the field’s converging interest in linking healthcare data with mortality data as a critical step to better understand the relationship between healthcare utilization patterns and mortality outcomes. The primary goal of this FOA is to solicit applications that propose to directly inform our understanding of mortality outcomes subsequent to healthcare visits. To accomplish this goal, we seek to support efforts that link data from healthcare systems to mortality data. While not an exhaustive list, applications that focus in the following areas would be considered of particular interest to the goals of this FOA:

• Among the largest public data sources (e.g., Medicaid and Medicare/CMS; Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project [HCUP]), seek proximal as well as longer term precursors of mortality outcomes among various cohorts (e.g., defined by care access patterns; demographic characteristics)
• Examine mortality-linked CMS and HCUP data at both the state and national level to track state and federal quality improvement progress in reducing suicide burden
• Facilitate linkage of private/commercial insurance health care data with mortality outcomes to enable research on patterns and predictors of suicide and other mortality in this population
• Examine precursors and their association to suicide and other mortality outcomes to probe whether targeting particular precursors would reduce suicide as well as other types of mortality

NIMHD is interested in applications that seek to better understand suicide risk and mortality in health disparity populations, including racial/ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Topics of specific interest include the following:

• Suicide risk factors and mortality within specific health disparity populations (e.g., across Asian or Hispanic subgroups).
• Patterns of suicide risk and mortality related to the intersection of multiple health disparity populations (e.g., mortality in rural vs. urban African Americans, race/ethnicity and sexual/gender minority status).
• Protective factors related to lower suicide mortality in particular health disparity populations, including African Americans, Hispanics/Latinos, and Asian Americans.
• Methods to generate more accurate estimates of probable suicide mortality for causes of death that are more prevalent in certain health disparity populations (e.g., firearm deaths, accidents, poisonings).

NCCIH is particularly interested in applications that:

• Examine data from health care records that include mortality outcomes and information about use of complementary or integrative approaches, including stepped care and collaborative models, to better understand predictors of suicide and factors that may reduce its occurrence. Examples of complementary and integrative approaches include mindfulness based stress reduction, meditation, yoga, acupuncture, and integrative care.
• Examine linkage of data from clinical trials, including pragmatic clinical trials, that examine complementary or integrative approaches, to mortality outcomes to better understand predictors of suicide and factors that may reduce its occurrence. Examples of complementary and integrative approaches may include mindfulness based stress reduction, meditation, yoga, acupuncture, and integrative care.

Applications that address questions using these combined/large datasets are strongly encouraged to consider: 1) work flow in healthcare systems that enhance efficiencies in timely, and sustained linkage processes of health care data to vital statistics; 2) subgroups of populations (e.g., age, economic status, rurality, sexual minority status) that may reveal differing healthcare utilization and mortality patterns, with implications for health care improvements.

In developing projects, applicants should consider what linked data in their application can be publicly shared. When possible, investigators funded by NIMH under this FOA are expected to share data via the NIMH Data Archive (https://data-archive.nimh.nih.gov/ndct/about). The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., electronic medical record data; National Death Index acquired data). The NIMH Data Archive can also provide a private cloud-based storage site that will facilitate the proposed work. Applicants who are interested in exploring this possibility should contact the NIMH Data Archive help desk (ndahelp@mail.nih.gov).

Pilot data are not required, but if a project is high-risk with limited preliminary results, it should be supported by a sound rationale as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful.

Applications that do not focus on specific, primary variables of relevance to understanding suicidal behavior and mortality outcomes will be deemed non-responsive and will not be reviewed.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)
• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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:

Email: NIMHReferral@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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:

Research Strategy: Research supported through this FOA should focus on novel, transformative approaches that leverage and aggregate existing healthcare datasets with that of mortality data to advance our understanding of suicidal behaviors. Applicants should make a compelling case as to how the proposed studies might yield insight regarding the etiology of suicidal behaviors. Sufficient details should be provided regarding the methodological approach and discussion of how this line of research will be beneficial to continued investigations focused on suicide. When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners and/or documented feasibility to obtain publically available data must be provided in the application. If linkage requires informed consent, documentation that such is permitted must be included. When possible, an application should propose to identify composite suicide risk and protective factors. Likewise, where appropriate, evaluation of moderators and mediators for suicide risk factor research should be considered. Applications should consider if there are unique circumstances for particular subgroups of populations (e.g., age, gender, cultural and sexual orientation differences) as they pertain to suicidal behaviors and outcomes. Finally, consideration regarding additional research avenues that might germinate from the proposed project should be described.

Current State-of-the-Art Statement: Investigators should clearly state the specific goals of their application, to include defining the current state of the science/technology as a benchmark against which the proposed research will be measured. Critically, applicants should provide an assessment of how their application will advance beyond the state-of-the-art, with an emphasis on how the proposed approach will yield informative benchmark data regarding mortality outcomes following medical treatment. Likewise, the application should describe how data from the proposed studies will result in meaningful and significant advances in understanding predictors and precursors of suicidal behaviors.

Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled Milestones , that briefly proposes operationally-defined indicators of progress at critical junctures. These junctions include the translation from pilot research, if needed, the plan for integrating healthcare datasets with measures or mortality outcomes, any statistical approaches that will be used to analyze the combined data, and any translational efforts to systematically evaluate and implement findings from this study. These milestones should be tailored to the unique scope of each project and written concretely enough to evaluate exactly what will have been achieved during the course of the project. The application should describe the potential implications of how the proposed research might extend beyond the purview of existing federal- and private-supported research. Investigators should describe how results will be used to inform future phases of research and development, particularly if these findings inform RDoC approaches.

Letters of Support: When multiple datasets are proposed to be aggregated, a clearly documented commitment by the data owners and/or documented feasibility to obtain publically available data must be provided in the application. If linkage requires informed consent, documentation that such is permitted must be included.

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. NIMH encourages use of common data elements (CDEs) identified through the PhenX collection, which includes suicide ideation and behavior, and many other psychiatric conditions (https://www.phenxtoolkit.org/), to enhance data sharing and synthesis. Applicants are encouraged to consider CDEs where appropriate.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Where relevant, has a compelling case been made regarding the significant added value for linking pertinent data from healthcare system records (e.g., suicide attempt events) to mortality data so that a more accurate understanding of the risk factors for, and the burden of, suicide among those seen in structured healthcare settings can be discerned? Has the application discussed how the proposed studies might yield insight regarding the etiology of suicidal behaviors? Will the findings from the proposed studies shed light on the type, severity, and timing of suicide predictors in the U.S.? Does the application describe how results will be used to inform future phases of research and development, particularly if these findings inform RDoC approaches?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

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 the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are sufficient details provided regarding the methodological approach and discussion of how this line of research will be beneficial to understanding suicide etiology? Have the specific goals of the application been delineated? Has the state of the art been accurately provided as a benchmark against which the proposed research will be measured? Does the proposed research plan describe a compelling advancement that will yield informative benchmark data regarding mortality outcomes following medical treatment or other care patterns? Has the application provided an assessment of how their application will advance beyond the state-of-the-art? Does the application describe how data from the proposed studies will result in meaningful and significant advances in understanding predictors and precursors of suicidal behaviors?

Are the proposed milestones operationally-defined and appropriate indicators of progress at critical junctions? Are these milestones tailored to the unique scope of the project and written concretely enough to evaluate exactly what will have been achieved during the course of the project? If the project is high-risk with limited preliminary results, has a sound rationale been provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful and are there clear milestones for integrating healthcare datasets with measures of mortality outcomes? Are the statistical approaches that will be used to analyze the combined data appropriate? If appropriate, are there clearly described plans to systematically evaluate and implement findings from this study? Does the application describe the potential implications of how the proposed research might extend beyond the purview of existing federal- and private-supported research? Does the application propose to identify composite suicide risk and protective factors? Does the application propose to evaluate moderators and mediators for suicide risk factor research? Is the application designed to consider subgroups of populations (e.g., age, gender, cultural and sexual orientation differences) as they pertain to suicidal behaviors and outcomes? If the application proposes to link multiple datasets, is there a clearly documented commitment by the data owners and/or documentation for the feasibility to obtain publically available data? If linkage requires informed consent, is documentation included that supports linkage? Does the application describe additional research avenues that might germinate from the proposed project?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

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

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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) Genomic Data Sharing Plan (GDS). If applicable, has the applicant adequately addressed approaches to use common data elements? Has the applicant described what linked data in their application can be publicly shared and how this will occur?

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573

Jay Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3621
Email: churchillj@mail.nih.gov

Jane Pearson, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3598
Email: jpearson@mail.nih.gov

Dave Clark, DrPH.
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 301-827-1916
Email: dave.clark@mail.nih.gov

Belinda E. Sims, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1533
Email: bsims@nida.nih.gov

Jennifer Alvidrez, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: alvidrezjl@mail.nih.gov

Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6697
Email: edith.davis@nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: CarowS@mail.nih.gov

Priscilla Grant
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Technical Assistance Teleconference

Technical Assistance teleconference will be held for potential applicants on September 11, 2017 from 1:00pm 2:00 pm EDT. The dial in number is 866-692-3158 and participant code is 5800728 #. NIH staff will be available to answer questions related to this FOA.

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 Part 75.