The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

In fiscal year (FY) 2008, NIMH released its first Strategic Plan, which guided

credit: Nathan Rouse

the Institute?s work toward this mission.

In March 2015, NIMH released its new Strategic Plan for Research.

Moving forward, the NIMH will be guided by both this new Plan and by the Strategic Research Priorities based on the Plan.



The Strategic Plan for Research comprises four high-level Strategic Objectives: (1) Define the mechanisms of complex behaviors; (2) Chart mental illness trajectories to determine when, where, and how to intervene; (3) Strive for prevention and cure; and (4) Strengthen the public health impact of NIMH-supported research.

The four Objectives of the Plan describe the continuum of mental health research, ranging from understanding basic pathophysiology, to defining the trajectories of mental illnesses, to developing innovative treatment and prevention strategies, to ensuring public health impact.

The Institute?s overall funding strategy is to support a broad spectrum of investigator-initiated research in fundamental science, with increasing use of Institute-solicited initiatives for applied research where public health impact is a short-term measure of success.



Cross-cutting themes relevant to all research supported by NIMH include the Research Domain Criteria Initiative; the Institute?s new experimental medicine approach, which focuses on studies with defined targets and milestones; the role of the environment in the pathogenesis of mental illnesses; the new culture of open science with broad and rapid data sharing; preemptive medicine; research designed to reduce and eliminate mental health disparities both within and outside the United States ? specifically, research on sex, gender, age, racial, and ethnic differences related to mental illnesses; partnerships with external stakeholders; and, supporting and training future generations of mental health researchers.



Specific program objectives include:

To determine the molecular, cellular, and systems components underlying brain connectivity and dynamic patterns of brain activity using model systems, and human studies; to identify the mechanisms responsible for establishing and maintaining circuits; to identify and validate novel assays to quantify changes in the activity of molecules, cells, and circuits; and, to elucidate the basic biology linking changes in molecular-, cellular-, and circuit-based targets to alterations in complex behaviors.

To define genomic variations associated with mental illnesses and determine the biological consequences of these variations; to define the molecular mechanisms that determine how experience has enduring effects on gene expression, brain function, and behavior; to delineate environmental and biological factors altering genomic risk for mental illnesses; and, to develop analytical tools for multi-scale data integration.

To identify cells and brain networks that contribute to various aspects of mental function and dysfunction, such as cognition, emotion, and social behavior; to determine how changes in the physiological properties of molecules, cells, and circuits contribute to mental illnesses; to develop biomarkers of impaired neural function in humans at the level of molecules, cells, and circuits; and, to develop innovative technologies, as well as new pharmacological and genetic tools, to interrogate and modulate the signaling pathways and circuits altered by mental illnesses.

To characterize developmental processes across biological and behavioral domains of analysis that give rise to mental illnesses throughout the lifespan; to identify sensitive periods for typical and atypical mental health trajectories; and, to determine modifiers of maturational and illness trajectories, emphasizing periods of sensitivity to perturbation and/or potential for intervention.

To identify early biological and environmental risk and protective factors and their underlying mechanisms to serve as novel intervention targets; and, to develop biomarkers and assessment tools to predict illness onset, course, and intervention response across diverse populations.



To identify and validate new targets for treatment development that underlie disease mechanisms; to develop and validate new metrics for target engagement that are feasible for use in clinical trials; and, to develop objective surrogate measures of outcome and clinical change that extend beyond symptoms, to assess if target mechanisms underlying general health and quality of life have been modified by treatments.

To develop valid and innovative biomarkers to detect subgroups of individuals sharing common etiologies ? whether within or across traditional diagnostic categories ? as well as aspects of emotion, cognition, and social behavior that predict clinical response; to foster personalized interventions and strategies for sequencing or combining existing and novel interventions that are optimal for specific phases of disease progression (e.g., prodromal, initial-onset, chronic), different stages of development (e.g., early childhood, adolescence, adulthood, late life), and other individual characteristics; and, to develop and refine alternative research designs and analytic approaches that can be used to test precise interventions.

To develop and test bundled intervention components (each validated individually in prior research) that have the greatest impact on patients? lives and functioning; together with key stakeholders, including patient, provider, payer, and other research funding groups, to conduct efficient pragmatic trials that employ new tools to rapidly identify, engage, assess, and follow participants in the context of routine care; and, to enhance the practical relevance of effectiveness research, taking into account how patient-, provider-, and organizational-level factors impact the outcomes of interventions in practice settings.

To employ existing real-world data collection systems to identify strategies for improving access, quality, and equity of mental health services in diverse populations; to identify, validate, and scale-up innovative programs currently in use that improve mental health services for underserved populations; to optimize financing models for adults and children with serious mental illnesses to provide efficient and effective care in public and private health care systems.

In partnership with key stakeholders, to develop and validate strategies for implementing, sustaining, and continuously improving evidence-based practices; to build models to scale-up effective interventions for use in public and private primary care, specialty care, and other systems; and, to develop decision support tools that increase the effectiveness and continuous improvement of mental health interventions in public and private primary care, specialty care, and other systems.

To develop systems-level strategies in non-traditional mental health settings, using technology and other approaches, to identify, support, and monitor the effectiveness of care for individuals with mental illnesses; to develop and validate service delivery models that provide responsive and pre-emptive evidence-based supports for individuals throughout the course of illness; and, to develop and validate coordinated medical decision-making models that bridge multiple social and medical care settings to integrate the appropriate care for people with serious mental illnesses and multiple chronic conditions.

To develop assessment platforms within service systems that allow ongoing monitoring of mental illness prevalence, service access, quality, efficiency of care, and outcomes for people with mental illnesses; and, develop valid and reliable measures of treatment quality and outcomes that can be feasibly applied at the person, clinic, system, and population levels.

To expand approaches to integrate behavioral science with effective biomedical strategies for HIV prevention; to advance the development and testing of interventions delivered beyond the individual level, by incorporating appropriate context into intervention development and testing; to increase intervention potency and long-term maintenance of effects, with an emphasis on targeting high-risk vulnerable populations; to develop strategies to increase HIV-testing and improve linkage to care and timely treatment initiation; to develop and test interventions to improve HIV treatment outcomes through optimal treatment adherence and sustained engagement in care; and, to support implementation science and operations research to enhance dissemination strategies and public health impact of effective interventions.

To examine evolving pathophysiologic mechanisms of HIV-associated neurocognitive disorders (HAND) in the setting of long-term antiretroviral therapy, and development of novel therapeutic approaches to mitigate CNS complications of HIV infection; to support the use of state-of-the-art genetic approaches to identify and validate viral and host genetic factors that influence the pathophysiology of HAND; and, to define and characterize HIV persistence in the CNS in the context of suppressive highly active antiretroviral therapy, and foster translational research to enable therapeutic eradication of HIV-1 from the brain.

Selected Recipients for this Program

Fiscal Year 2016: 2,788 grants were awarded. Fiscal Year 2017: An estimated 2,834 grants will be awarded. Fiscal Year 2018: Estimate Not Available.

Uses and Use Restrictions

Research project grants provide support for clearly defined projects by a named investigator in an area representing his/her specific interests and competencies.

Exploratory/Development and Clinical Exploratory/Developmental Grants encourage the development of new research activities in categorical program areas.

Small Research Grants provide research support specifically limited in time and amount for studies in categorical program areas.

Collaborative Clinical Research Grants support evaluations of various methods of therapy and/or prevention.

Program Project and Center grants support large-scale, broad-based programs of research, usually interdisciplinary, consisting of several projects with a common focus.

Cooperative Agreements support single or a group of related research activities with greater involvement of federal staff.

SBIR and STTR grants are awarded in two stages: Phase I grants are awarded to establish the technical merit and feasibility of a proposed research and development effort; only Phase I awardees are eligible to receive Phase II support.

Mentored Research Scientist Development Award (K01, MRSDA), Mentored Clinical Scientist Development Award (K08, MCSDA), and Mentored Quantitative Research Career Development Award (K25) provide support for individuals with research potential who need additional mentored development and/or experience in a productive research environment.

Mentored Patient-Oriented Research Career Development Award (K23) supports the career development of individuals who have made commitment to focus their research endeavors on patient-oriented research.

The NIH Pathway to Independence (PI) Award (K99/R00) provides up to 2 years of mentored support (K99) for a postdoctoral individual followed by up to 3 years of support after the awardee transitions to research independence (R00).

K99/R00 awards are awards for up to 5 years of support.

Salary support for all mentored awards may be supplemented by the sponsoring institution from nonfederal funds.

The Independent Scientist Award (K02, ISA) is for independent scientists whose careers are developing rapidly; the Mid-career Investigator Award in Patient-Oriented Research (K24) is for outstanding clinical scientists engaged in patient-oriented research.

No specialized training costs are available; limited research costs for K24s and K02s in theoretical areas are available.

NRSA awards: Individual fellowships are made to students seeking predoctoral or postdoctoral support for full-time research training or who are enrolled in an formal Ph.D.

or M.D./Ph.D.

program.

An institutional allowance will be provided to the sponsoring institution for each awardee.

In addition, any domestic public or nonprofit institution may apply for an institutional research training grant in a specified area of research from which a number of stipend awards will be made to individuals selected by the training program director at the institution.

Support is available for both predoctoral and postdoctoral trainees and will include an amount for institutional expenses.

Indirect costs may be requested at 8 percent of total direct costs, exclusive of tuition and related fees and expenditures for equipment, or actual indirect costs, whichever is less.

Postdoctoral students receiving fellowships or stipend support under either individual or institutional grants for 12 months or less are obligated to pay back this support through an equivalent period of continued postdoctoral training or a period of health related research and/or teaching activities after the completion of their training.

Postdoctoral individuals in their thirteenth and subsequent months of support will incur no further obligation, and such support will be considered acceptable postdoctoral payback service.

Research training support may not be used for internships or other clinical training.

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Eligibility Requirements

Applicant Eligibility

Public, private, -profit, or nonprofit agencies (including State and local government agencies), eligible Federal agencies, universities, colleges, hospitals, and academic or research institutions may apply for research grants.

SBIR grants can be awarded only to domestic small businesses, and STTR grants can be awarded only to domestic small businesses which 'partner' with a research institution in cooperative research and development.

An applicant for individual predoctoral fellowship support must be enrolled in a research doctoral degree program by the proposed activation date of the fellowship.

A postdoctoral applicant must have received a Ph.D., Psy.D., M.D., D.D.S., Sc.D., D.N.S., D.O., D.S.W., or equivalent degree from an accredited institution to be eligible for an individual postdoctoral fellowship.

All research training awards are made to appropriate domestic research centers, medical schools, departments of psychiatry, non-medical academic departments, psychiatric hospitals or hospitals with psychiatric services, community mental health centers, and biomedical research institutes on behalf of individuals who need the opportunity to realize research potential.

Except for the NIH Pathway to Independence (PI) Award (K99/R00), the individuals must be citizens or nationals of the United States or have been lawfully admitted for permanent residence.

The NIH Pathway to Independence (PI) Award (K99/R00) is open to both U.S.

citizens and non-U.S.

citizens.

Individuals must qualify by scholastic degree and previous training and/or experience.

Beneficiary Eligibility

Individuals and public, private, profit, or nonprofit organizations.

Credentials/Documentation

For-profit organizations' costs will be determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For all other grantees, costs will be determined in accordance with HHS Regulations 45 CFR 75. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Instructions for electronic submission may be found with the federal SF424 (R&R) form packages that are found in the SBIR/STTR funding opportunity announcements. Instructions are provided for SBIR Phase I and Phase II awards, respectively; as well as for STTR Phase I and Phase II awards, respectively. The cost principles for awards under this program are set forth in HHS regulations at 45 CFR 75, Subpart E and Appendix IX (hospitals) to Part 75. Commercial organizations are subject to the cost principles located at 48 CFR 31.2 Federal Acquisition Regulation. See the NIH Grants Policy Statement for further guidance on the applicability of cost principals (http://grants.nih.gov/grants/policy/nihgps/index.htm). 2 CFR 200, Subpart E - Cost Principles applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Most applications must be prepared and submitted electronically. Most applicants use the SF 424 (Research & Related) for electronic submission. Information about the SF 424 form may be found on http://grants.nih.gov/grants/funding/424/index.htm, but application packages should be accessed through the appropriate funding opportunity announcement, found either on the NIH Guide for Grants and Contracts (http://grants1.nih.gov/grants/guide/index.html) or through the Grants.gov website (http://www.grants.gov/). Some institutions may submit the grant data directly (using what is called a system-to-system transfer). For further details, see grants.gov or eRA Commons. Application forms for SBIR and STTR grants may be obtained through the SBIR/STTR funding announcements posted on the NIH Guide for Grants and Contracts and the Grants.gov sites (see URLs listed above). All SBIR and STTR applications must be submitted electronically. The timeline for transition to electronic applications and the new forms may be found at: http://era.nih.gov/ElectronicReceipt/. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Consultation on a proposed project may be obtained from the NIMH branch or office responsible for the research area of interest. Applications are reviewed by principally nonfederal consultants recruited nationwide from the mental health field. The amounts of the award and period of support are determined on the basis of merit of the project and the nature of the grant mechanism. Electronic applications are submitted through the Grants.gov website. Awards made under this program are subject to 2 CFR 200, as implemented by 45 CFR 75 ?Public Welfare, Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards?. The policies and procedures generally applicable to NIH grants are set forth in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/index.htm).

Award Procedures

All applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel. Applications other than fellowships must also be reviewed by the National Advisory Mental Health Council . All competitive applications compete for available funds on the basis of scientific and technical merit, program relevance, and program balance. All SBIR and STTR applications receiving a priority score compete for set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

SBIR/STTR Reauthorization Act of 2011; Public Health Service Act, Title IV, Section 401(a), 42 U.S.C 281; Public Health Service Act, Title III, Section 301, 42 U.S.C 241.

Range of Approval/Disapproval Time

> 180 Days. Applications: From 180 to 270 days from submission of application. SBIR/STTR applications: About 7- 1/2 months; AIDS-related research is expedited and a determination is made within 180 days.

Appeals

A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH homepage http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.

Renewals

Support is recommended for a specified project period, not in excess of 5 years. Prior to termination of a project period, the grantee may apply for renewal of support for a new project period. An application for renewal is processed as a new competing request. Small grants, exploratory, and dissertation grants are for 1-3 years (depending on program) and are not renewable. By law an individual may receive no more than 6 years of support in the aggregate at the predoctoral level and no more than 3 years of support in the aggregate at the postdoctoral level under the NRSA program (through an individual and/or institutional award). Any exception to these limitations requires a waiver from the Director of the awarding Institute based on review of justification from the awardee and the program director for the institutional grant. K01, K08, K23, K25 awards are made for up to 5-year periods with no renewal. K02 and K24 awards are made for a 5-year period, renewable once (unless holder has held a previous K02 or K24 award). K99 awards are made for up to 2-year periods with no renewal.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula. This program has no matching requirements. This program does not have MOE requirements.

Length and Time Phasing of Assistance

Varies, with a project periods ranging from 1 to 5 years. Funding commitments are made annually. See the following for information on how assistance is awarded/released: A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. SBIR: Generally, Phase I awards are for 6 months, and Phase II awards are for 2 years. STTR: Generally, Phase I awards are for 1 year and Phase II awards are for 2 years. Information on how assistance is awarded/released: A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. By law an individual may receive no more than 6 years of support in the aggregate at the predoctoral level and no more than 3 years of support in the aggregate at the postdoctoral level under the NRSA program (through an individual and/or institutional award). For an M.D./Ph.D. fellowship, 6 years may be requested. In practice, recommendations of review committees are generally for 2 or 3 years. See the following for information on how assistance is awarded/released: A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.

Post Assistance Requirements

Reports

No program reports are required.

No cash reports are required.

Reports must be submitted as follows: (1) Interim progress reports annually as part of a non-competing application for previously recommended support; (2) terminal progress report within 90 days after end of project support.

Annual financial status report within 90 days after termination of annual grant for some programs.

In addition, immediate and full reporting of any inventions is required.

No performance monitoring is required.

Audits

In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials. Per the regulations, a for-profit (commercial) organization is subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is a HHS grant. For-profit organizations have two options regarding the type of audit that will satisfy the audit requirements either: (1) a financial related audit (as defined in the Government Auditing Standards, GPO Stock #020-000-00-265-4, http://www.gao.gov/govaud/ybk01.htm) of the HHS awards in accordance with Government Auditing Standards, or (2) an audit that meets the requirements contained in OMB Circular No. A-133(http://www.whitehouse.gov/OMB/circulars/a133/a133.html). Awards made under this program are subject to the audit requirements of OMB 2 CFR 200, as implemented by 45 CFR 75, Subpart F, and in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/index.htm).

Records

Records must be retained at least 3 years; records shall be retained beyond the 3-year period if audit findings have not been resolved.

Financial Information

Account Identification

75-0892-0-1-552.

Obigations

(Project Grants) FY 16 $1,197,285,071; FY 17 est $1,274,384,254; and FY 18 Estimate Not Available - These figures represent total base dollars for Research Grants, SBIR/STTR, and NRSA training grants.

Range and Average of Financial Assistance

$1 to $8,926,711; $429,174.

Regulations, Guidelines, and Literature

42 CFR 52. NIH Grant Policy Statement (Revised 12/2003). Grants will be available under the authority if and administered in accordance with the PHS Grants Policy Statement and federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Applications; and Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer Grant Applications.

Information Contacts

Regional or Local Office

None.

Headquarters Office

Jean Noronha, Ph.D. 6001 Executive Blvd, Rockville, Maryland 20892-9609 Email: nimhreferral@mail.nih.gov Phone: (301) 443-3367 Fax: (301) 443-4720

Criteria for Selecting Proposals

The following consideration will be used in determining projects to be funded: (1) Technical merit of the proposed project as determined by peer review; (2) Availability of funds; and (3) Relevance to program priorities.