Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R43/R44)

Activity Code

R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track

Announcement Type

New

Related Notices

  • April 30, 2014 - This PA has been reissued as PA-14-197.
  • July 19, 2011 - See Notice NOT-MH-11-015 The purpose of this Notice is to alert small businesses to high program priorities relevant to the SBIR program of the National Institute of Mental Health (NIMH).

Funding Opportunity Announcement (FOA) Number

PA-11-133

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic
Assistance (CFDA) Number(s)

 93.242  

FOA Purpose

The overarching goal of the SBIR program at the National Institute of Mental Health (NIMH) is to support small businesses to develop technologies that can advance the mission of the Institute, including in basic neuroscience research relevant to mental disorders, translational and clinical research of mental disorders, clinical diagnosis or treatment of mental disorders, and dissemination of evidence-based mental health care.  This FOA encourages SBIR applications for support of research and development of particular types of complex technologies that require funding levels and durations beyond those reflected in the standard SBIR guidelines. 

Key Dates
Posted Date

February 25, 2011

Open Date (Earliest Submission Date)

March 5, 2011

Letter of Intent Due Date

Not applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January  8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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 of the FOA. When the program-specific instructions in the FOA 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The overarching goal of the SBIR program at the National Institute of Mental Health (NIMH) is to support small businesses to develop technologies that can advance the mission of the Institute, including in basic neuroscience research relevant to mental disorders, translational and clinical research of mental disorders, clinical diagnosis or treatment of mental disorders, and dissemination of evidence-based mental health care.  The NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) presents key scientific priorities across these domains, and describes the need for tools to realize these priorities. Research priorities for the NIMH further include aspects of HIV/AIDS prevention, treatment, and care, in accordance with the Trans-NIH Plan for HIV-Related Research (http://www.oar.nih.gov/strategicplan/).

The SBIR program is one source of support for the research and development of technologies that correspond to these identified research priorities.  While some tools can be developed with budgets and project durations within the standard SBIR guidelines, others cannot.  This FOA encourages SBIR applications for support of research and development of particular types of technologies that require funding levels and durations beyond those reflected in the standard SBIR guidelines.  For additional tools in which NIMH is interested, but which can be supported within the standard SBIR guidelines, see the NIMH-related topics of the SBIR Omnibus Solicitation - PAR-11-096

Applications submitted in response to this FOA are expected to represent significant advances and innovation. 

Specific Areas of Research Interest:

Biomarkers and Biosignatures of Mental Illness:

Biomarkers are objective, measurable biochemical, genetic, or other biological indicators of a physiological or disease process. While some individual biomarkers are useful in biomedicine, complex conditions such as mental illness (including HIV-related neurological and neuropsychiatric impairment) might benefit from constellations of several different biomarkers being considered together (i.e., biosignatures). Whether used alone or in conjunction with others, biomarkers could facilitate definitive diagnosis of mental disorders in individuals, assess the susceptibility of individuals to a particular disorder, indicate changes in the severity of a disorder, show the response of a disorder to a given treatment, or the likely responsiveness of a particular patient to a given intervention. Biomarkers and biosignatures would have clear and significant clinical benefit, and are urgently needed.  NIMH is specifically interested in supporting the development of clinically applied indicators as well as those useful in basic brain or behavioral research. Ideally, these would be noninvasively obtained (e.g., using optical or magnetic resonance imaging, etc.), or obtained with minimal invasiveness (e.g., from body fluids using genetic, protein or metabolic signatures, physiological measures, etc.).  Specific examples of clinical applications include: reliable and stable biomarkers that can identify at-risk individuals prior to disease onset, biological and behavioral indicators of treatment response, measures of disease progression, to identify dose ranges prior to clinical studies, to define patients to enroll in the clinical study, to identifying CNS abnormalities, etc.  Specific examples of basic research applications: indicators that enable refined assessment of normal and atypical infant, child and adolescent brain development and brain function, biomarkers for assessing changes in specific mental functions over the lifespan. Either human subjects or relevant animal models would be appropriate to use in basic research applications. It is important to note that these examples are merely illustrative and are not meant to limit the scope of appropriate applications.

Drug Discovery/Drug Development in Mental Illness:

Through the SBIR program, NIMH continues to support the development of pharmacologic agents that target novel molecular entities, relevant to mental health disorders, or domains of function (e.g. cognitive function).  In the last decade, only a relatively small number of drugs have been approved for the treatment of mental health disorders, and most were chemically based on older marketed compounds.  In addition, none specifically targeted neurodevelopmental epochs at which a mental health disorder’s symptoms may begin to appear.  The lack of such compounds not only may be limiting the utility of such interventions for pediatric populations, but may also be missing a key juncture at which intervention might have particularly long-term benefits.  NIMH is specifically interested in supporting the development of pharmacologic agents, based on novel molecular CNS targets that improve function and minimize the side effects seen with current medications. In addition, compounds targeted for the treatment of pediatric mental health disorders would also be of interest.  SBIR support in drug discovery/development is broad and ranges from the development of novel ligand screening assays (such as computational, high throughput, genetic, molecular/cellular, or whole animal) to novel chemistry approaches, to lead compound identification/optimization preclinical efficacy, IND-enabling studies, and up to FDA Phase I and II clinical trials.  Novel clinical trial designs/approaches would also be applicable, if well justified.

An additional focus in this area is the support of technologies that would enable researchers to selectively screen for compounds with high selectivity to Central Nervous System (CNS)-located G-protein coupled receptor proteins (GPCRs).  Many of the GPCRs have potential significance in healthy mental function and in mental disorders, including receptors for serotonin, glutamate, dopamine, opioids, GABA, orexins, somatostatin, muscarinic, cannabinoid, adrenergic, Neuropeptide Y, corticotropin releasing factor (CRF) and others.  Drugs targeting GPCRs are currently used in the treatment of mental health disorders such as schizophrenia, anxiety and depression.  Yet identification or synthesis of selective agonists and antagonists to these particular receptor subtypes has proved daunting, due to the current lack of knowledge about the three dimensional (3-D) structure of many of these receptors, and their diffuse brain distribution. , Therefore, this FOA encourages the development of technologies to aid in the identification of their 3-D structures or in some other way, enable researchers to selectively screen for compounds with high selectivity to the receptor (and minimize side effects). Technologies and approaches aimed at either known receptor subtypes or orphan receptors would be of potential interest.

Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders:

The NIMH Division of AIDS Research (DAR) encourages SBIR applications targeting the discovery and development of novel therapeutic agents, methods, biomarkers, and drug delivery technologies that can address the neurological implications of HIV infection and seek to directly or indirectly eliminate/eradicate HIV reservoirs in the brain.  The overriding focus is upon the development of adjunctive therapies against the consequences of HIV in the central nervous system, but novel assays/models of neurotoxicity and treatment efficacy measures are also invited, as well as novel in vitro/vivo models that can be used for screening potential therapeutic agents.

Development of PET and SPECT Ligands for Brain Imaging: 

This topic is intended to stimulate the development of radioligands for CNS- relevant molecular targets (e.g., receptors, cell adhesion molecules, intracellular messengers, and disease related proteins) that are of interest to the mental health scientific community. The widespread availability and use of these radioligands are expected to: 1) accelerate research on identifying and characterizing the neural circuits and pathways implicated in the pathophysiology of psychiatric brain disorders and HIV-associated neurological and neuropsychiatric impairment, and 2) facilitate the identification of new therapeutic targets and the development of new compounds as potential therapeutic agents.  Research support under this topic includes: lead compound identification, preclinical studies, IND-enabling studies, pilot human imaging studies in normal volunteers and clinical studies in psychiatric populations.

Tools to Facilitate Mental Health Research:

The complexity of conducting and managing mental health research is significant due to the diverse technologies/methodologies currently being used, difficulty in the recruitment of subjects, broad categorical diagnoses of disorders, unique cultural and developmental aspects of a disorder, etc.  Therefore, the NIMH seeks the development of innovative technologies/strategies to help mitigate some of these issues. 

Examples could include  one or more of the following: technologies to improve clinical research recruitment, patient and doctor compliance, clinical trial design or implementation; the application of technology to enhance the science, operation, and management of large or multi-site mental health or HIV/AIDS clinical trials; the development of innovative computer-based observation techniques, and computer software and hardware that facilitate screening, assessment and monitoring during clinical trials; the development of portable clinical trial management systems such as serious adverse event (SAE) oversight and monitoring software; advanced methods to visualize complex clinical and biological data; development of real time risk assessments or a clinical tool that enables clinicians to quickly recognize a change in patient health and therefore improve clinical care.

The NIMH is also supportive of the development and implementation of robust rapidly scalable data systems that can safely and efficiently import and house core data from multiple independent sources (i.e. large health care providers) and from different hardware platforms. Such systems would effectively categorize, merge and aggregate data from multiple independent sources and would utilize a core data element structure. This system would enable researchers to easily access the system, identify potential research subjects, analyze clinical data, produce reports and “data mine.”

Tools/Platforms to Improve the Dissemination and Implementation of Evidence-Based Mental Health Interventions:

Clinical mental health research produces a vast amount of information that should be informative to mental health care providers, yet there are no easy ways for this information to be transformed into standard clinical practice.  Similar concerns have been noted with regard to advancing the uptake and sound implementation of efficacious HIV prevention and care interventions by HIV providers, clinics, and community-based organizations.

The NIMH supports the development of innovative user-friendly tools and platforms to efficiently and effectively disseminate evidence-based treatments/research into services and clinical practice. Such tools may incorporate applied behavioral science and technology, software, hardware and associated technologies. The focus of the information being disseminated might include: the development of strategies or tools to assist mental health care providers in detecting and monitoring mental illness progression, in implementing proven interventions, or in predicting treatment response and vulnerability to side effects of psychotropic medications.  Systems may also seek to advance the identification, dissemination, adoption, or effective implementation of evidence-based behavioral interventions for HIV prevention and care.

Additional NIMH interests include the development of geographic based systems (GIS) that can identify disparities in mental health treatment and demonstrate the impact of the effective dissemination of proven mental health treatments across and within geographic areas. The NIMH holds further interests in data translation and communication packages for collecting, archiving, and safely and securely making available existing mental health and HIV/AIDS data sets to the scientific community for secondary or meta-analyses.  It is expected that the dissemination platform be state of the art, considering the latest electronic technologies, so as not to develop a tool that becomes obsolete during the commercialization phase.  In addition, dissemination of interventions that have not been well-validated would not be appropriate for commercialization.

Probes and Instrumentation for Monitoring and Manipulating Nervous System Plasticity and Development: 

Mental disorders are increasingly seen as developmental disorders.  The potential to harness neuroplasticity -- to enhance the ability of the nervous system to reshape and form new connections -- may be the basis for therapeutic approaches to disorders such as post-traumatic stress disorder, and cognitive impairment. Thus, understanding neural development and plasticity at all levels, from molecules and cells to circuits and behavior, has broad implications for mental health.  The NIMH SBIR program continues to support the development of tools or techniques that will significantly advance the current state of the art in neuroplasticity research. Although applications will not be restricted to developing a particular type of technology, we are especially interested in applications that seek to harness the ability to assess and manipulate activity with exquisite subcellular resolution, and in cells specified by their circuit connectivity and/or transmitter phenotype.  Examples include: new or enhanced reporters of neural activity, novel tools for manipulating neural circuits, and improved imaging equipment.

Computational Tools for Research in Neuroscience, Behavioral Science and Mental Health: 

The NIMH has a longstanding interest in developing and seizing the promise that digital approaches hold for brain and behavioral research, and for advancing the understanding, prevention, and treatment of mental disorders. In accord with that interest, grant applications are sought from small businesses that propose to develop and validate novel, commercializable, computational tools and resources that will aid neuroscientists, mental health researchers, or mental health providers in their research or practice.  Examples of appropriate applications range from computational models for drug discovery in mental health disorders or HIV-associated CNS disorders, to ones that combine genetic, biological, behavioral and environmental factors to assess pediatric vulnerability to mental disorders, to methods to enhance efficiency of early phase clinical trials.  These examples are not meant to be exclusive.

High Throughput Tools for Neuroscience and Mental Health Research: 

Many of the common technologies used in neuroscience and behavioral science research require extensive time, labor, and cost for acquiring and analyzing data.  With many significant advances in technical areas including computer vision, molecular biology, robotics, nanotechnology, microarray fabrication, imaging, etc. occurring over the last decade, combined with discoveries in neurobiology, a unique opportunity is available to bring these technology and biomedical areas together to develop innovative high throughput tools relevant to brain and/or behavior.  Applications considered appropriate to this topic would include those proposing research and development of tools for high throughput measures at any level (or combination of levels) of analysis: from genes and molecules through behavior, including cognition and social behavior. The tools would, of course, need to be aimed at rapid acquisition and analysis of data, such as the collection of CNS physiological data from multiple subjects at one time. While the range of measures by tools is wide, appropriate applications must propose research and development of tools that would significantly improve the ability to rapidly acquire data from multiple experiments simultaneously, and rapidly analyze the collected data.

Nanotechnologies for Neuroscience and Mental Health Research: 

Nanotechnologies are showing promise in diverse roles highly relevant to NIMH priorities.  In particular, NIMH is interested in nanotechnologies that focus on a variety of technologies including:  the development of extended release formulations of psychiatric drugs, biomarker assays, probes for microimaging, in vitro assays to study neuronal function, and assays to allow GPCR function to be studied.  NIMH is further interested in nanotechnology to address HIV-associated neurological and neuropsychiatric impairment, particularly with regard to the delivery of antiretroviral medications or neuroprotective compounds across the blood-brain barrier.

An additional criteria that the federal government considers in supporting a small business with SBIR funds, is past commercialization performance.  It is expected that small businesses who have received many SBIR grants, have made significant effort to commercialize their previously supported technologies.  Small businesses that are mostly interested in research and development (and not commercialization) should consider other grant mechanisms at NIH, rather than the SBIR program.  Program staff at NIMH can help identify the most appropriate grant mechanism to use. 

Additional information about NIMH research interests may be found here:

1)  NIMH Strategic Plan:  http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml

2)  NIH SBIR website:   http://grants.nih.gov/grants/funding/sbir.htm

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed
 

New (Phase I, Fast-Track)
Renewal (Phase II)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB, formerly Phase II Competing Renewal)
Revisions (allowed for all except Phase IIB)

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

For this FOA, budgets up to $350,000 total costs per year for Phase I and up to $600,000 total costs per year for Phase II may be requested for these technology areas listed in the  research objectives:  biomarkers/biosignatures, drug discovery/development, HIV/AIDS therapeutics, PET/SPECT ligands, tools to facilitate mental health research, and tools to improve dissemination,  Budgets up to $300,000 total costs per year for Phase I and up to $500,000 total costs per year for Phase II may be requested for these technology areas listed in the research objectives:  probes for monitoring neuroplasticity, computational tools, high throughput tools, and nanotechnologies.  

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.

Award Project Period

For this FOA, durations up to two years for Phase I and up to three years for Phase II may be requested.

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1.  Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2.  Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;

3.  Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States,  or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4.  Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR 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.

All Program Directors/Principal Investigators (PD/PIs) 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 least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

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

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

Contractual/Consortium Arrangements

In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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.

Required and Optional Components

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

Page Limitations

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

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

Resource Sharing Plans

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

Appendix

Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide,

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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) SBIR/STTR Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete  will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria

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 project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase IIB Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)   

Investigator(s)

Are the PD/PIs, 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?     

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?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

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 arrangement?   

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Phase II Applications

For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

Phase I/Phase II Fast-Track Applications

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

For Phase IIB Applications (formerly called Phase II Competing Renewals), the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.  Revisions are not allowed for Phase IIB applications.

Additional Review Considerations

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/priority score.

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF424 (R&R) SBIR/STTR Application Guide.

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. 

Section VII. Agency Contacts

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

Prospective applicants are encouraged to contact NIMH program staff listed in this FOA to discuss their projects.

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Margaret C Grabb, PhD
Chief, SBIR and STTR Programs
National Institute of Mental Health
Telephone:  (301) 443-3563
Email:  mgrabb@mail.nih.gov

Michael J. Stirratt, Ph.D.
Division of AIDS Research
National Institute of Mental Health
Telephone:  (301) 443-6802
Email:  stirrattm@mail.nih.gov

Adam Haim, Ph.D.
Clinical Trials Operations and Biostatistics Unit (CTOB)
National Institute of Mental Health
Telephone:  (301) 435-3593
Email: haima@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Jane Lin
National Institute of Mental Health
Telephone: (301) 443-2229
Email: linja2@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act).The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.


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