Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Mental Health (NIMH) |
|
Funding Opportunity Title |
Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R41/R42) |
Activity Code |
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-14-196 |
Companion Funding Opportunity |
PA-14-197, R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.242 |
Funding Opportunity Purpose |
The overarching goal of the Small Business Technology Transfer (STTR) 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 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 STTR grant applications to support research and development of particular priority research topics - complex technologies that require funding levels and durations beyond those reflected in the standard STTR guidelines. |
Posted Date |
April 30, 2014 |
Open Date (Earliest Submission Date) |
July 5, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Standard AIDS dates apply. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
New Date January 6, 2018 per issuance of NOT-MH-17-024. (Original Expiration Date: April 6, 2017) |
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. 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
The overarching goal of the STTR 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 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 STTR 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 STTR guidelines, others cannot. This FOA encourages STTR applications for support of research and development of particular types of technologies that require funding levels and durations beyond those reflected in the standard STTR guidelines. See Appendix A of the SBIR/STTR topics list for a complete list of technology areas that received a SBA budget waiver to expand budgets beyond the caps, when appropriate, (https://grants.nih.gov/grants/funding/sbirsttr1/2014-2_SBIR-STTR-topics.pdf ). 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 STTR Omnibus Solicitation Parent FOA.
Applications submitted in response to this FOA are expected to represent significant advances and innovation.
Biological Markers: A biological marker or biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. A biomarker can be a physiologic, pathologic, or anatomic characteristic or measurement that is thought to relate to some aspect of normal or abnormal biologic function or process.
Biomarkers measured in patients before treatment can be used to select patients for inclusion in a clinical trial. Changes in biomarkers following treatment may predict or identify safety problems related to a candidate drug, or reveal a pharmacological activity expected to predict an eventual benefit from treatment. Biomarkers can help reduce uncertainty in drug development and evaluation by providing quantifiable predictions about drug performance and they can contribute to appropriate dose selection.
A composite biomarker consists of several individual biomarkers that are combined in a stated algorithm to reach a single interpretive readout (Qualification Process for Drug Development Tools, Qualification Process Working Group, Center for Drug Evaluation and Research, the Food and Drug Administration).
Consistent with the RDoC initiative, NIMH encourages studies that focus on identifying biomarkers for narrowly-defined clinical problems that span traditional diagnostic categories and relate to one or more of the RDoC neurobehavioral domains (i.e., social processes, negative valence, positive valence, cognition, and arousal/regulatory processes).
Of greatest interest are biomarkers that influence practice because they predict treatment outcome or prognosis. The development of innovative biosensors would also be of interest.
Drug Discovery/Drug Development in Mental Illness: Through the STTR 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 fifteen years, 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 an intervention might, in particular, have 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. STTR 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, lead compound identification/optimization, preclinical efficacy, IND-enabling studies, and early stage clinical trials. Novel clinical trial designs/approaches would also be applicable, if well justified. Note that applications involving clinical trials must follow the format outlined in NOT-MH-14-007.
Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders: The NIMH Division of AIDS Research (DAR) encourages STTR 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 development of 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.
Tools to Facilitate Basic Neuroscience and Mental Health Research: The complexity of conducting and managing basic neuroscience and mental health research is significant due to the diverse technologies/methodologies currently being used and the vast amounts of data being obtained, 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; state of the art technologies for collecting and/or analyzing basic neuroscience research; 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, state of the art, 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. The NIMH also supports the development of novel technologies to monitor mental health and/or care delivery in a real-time, accessible, effective, and minimally obtrusive way. These may include novel sensor or monitoring systems, mobile based software, and data driven information systems which have the goal of preventing and treating mental illnesses.
The NIMH Division of AIDS Research (DAR) encourages SBIR applications that focus on advancing the identification, dissemination, adoption, or effective implementation of evidence-based interventions and practices in HIV prevention and care. Of particular interest are innovative technologic tools designed to optimize patient engagement, adherence, and retention in the HIV care continuum. In addition, tools utilizing advanced technologies are needed to increase HIV testing (including frequent repeat testing and self-testing) and to better identify and support individuals for whom evidence-based biomedical prevention interventions such as pre-exposure prophylaxis (PrEP) are indicated.
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 STTR 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.
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.
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://sbir.nih.gov
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed
|
New (Phase I, Fast-Track) 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 |
According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($225,000 for Phase I and $1,500,000 for Phase II). NIH has received a waiver from SBA, as authorized by the statute, to exceed the hard cap for specific topics. The list of approved topics can be found in Appendix A at the end of PHS 2014-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA and ACF. Please also refer to the appropriate Institute’s or Center’s topic section to determine whether they will consider applications above these amounts. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. 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 |
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.
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 must be less
than 50 percent participation by foreign business entities in the joint
venture;
3. (i) SBIR and
STTR. Be a concern which is more than 50% directly owned
and controlled by one or more individuals (who are citizens or permanent
resident aliens of the United States), other business concerns (each of which
is more than 50% directly owned and controlled by individuals who are citizens
or permanent resident aliens of the United States), or any combination of
these; OR
(ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
(iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.
4. Has, including its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
Definitions:
- Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
- Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
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.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Phase I to Phase II Transition Rate Benchmark
In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011. This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.
Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The benchmark minimum Transition Rate is 0.25.
SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, may be 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, SBA Company registry, 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.
- SBA Company Registry New requirement. See Section IV. Application and Submission Information, SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
- 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 the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept 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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
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.
In Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of the SF424 (R&R) application forms.
A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.
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 PHS 398
Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR
Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.
Instructions for Application Submission
The following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Other Attachments:
1. SBA Company registry
All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.
a. Navigate to the SBA Company Registry.
b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .
c. If you are a first time applicant, click the "New to the SBIR Program?" link on lower right of registry screen.
d. Fill out the required information on the Basic Information and Eligibility Statement screens.
e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.
f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the Research and Related Other Project Information form.
For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
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. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide. Note that Phase I SBIR/STTR Appendix materials are not permitted.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
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) SBIR/STTR 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) 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(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.
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 (SAM). 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.
Applicants are required to follow our Post Submission Application Materials policy.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 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 II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
Investigator(s)
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?
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 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?
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?
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.
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 Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
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.
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.
Phase IIB Competing Renewals
For Phase IIB Applications, 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.
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.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
Scientific Review, 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 committee 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.
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 National Advisory Mental Health Council. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique) via
the eRA
Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy
Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
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.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
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.
- Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152)
- Final Invention Statement and Certification (HHS 568)
- Annual Invention Utilization Reports
- Federal Financial Report (FFR) replaced the Final Cash Transaction Report (PSC 272)
- Phase II Data Collection Requirement for Government Tech-Net Database
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-945-7573
TTY: 301-451-5936
Email: [email protected]
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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]
SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg.
For questions involving basic neuroscience technologies, pediatric technologies, drug development or biomarkers:
Margaret C. Grabb, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: [email protected]
For questions involving AIDS/HIV- focused technologies:
Rebecca delCarmen Wiggins, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3635
Email: [email protected]
For questions involving IT enhanced technologies or mental health services:
Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-3593
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50 and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.
