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)

National Institute of Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Drug Abuse (NIDA)  

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Funding Opportunity Title

BRAIN Initiative:  Development, Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (STTR)(R41/R42)

Activity Code

 R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-090

Companion Funding Opportunity

February 19, 2015 - See Companion PAR-15-121.
PAR-15-091, 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, 93.866, 93.273, 93.279, 93.853, 93.173  

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the through the Small Business Technology Transfer (STTR) program to advance the field of neuroscience research, including 1) tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function, 2) proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain, and 3) iterative refinement of such tools and technologies with the end-user community with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.     

Key Dates
Posted Date

January 16, 2015

Open Date (Earliest Submission Date)

March 5, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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)

Not Applicable

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

January 6, 2018

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.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
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
Background

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative is a Presidential project aimed at revolutionizing our understanding of the human brain.  By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space.  It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat, cure, and even prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative.  Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This report can be found at http://braininitiative.nih.gov/.  This FOA and other FOAs issued in Fiscal Year 2015 are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group (http://braininitiative.nih.gov/MCWG-Roster.pdf), which held its first meeting on August 25th, 2014 (see http://videocast.nih.gov/summary.asp?file=18555&bhcp=1). 

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research.  The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research efforts through applications received via parent announcements as well as through specific funding opportunity announcements.  Potential applicants to this FOA are strongly encouraged to contact Scientific/Research staff if they have any questions about the best funding opportunity announcement for their research.

Research Objectives

Based on the priority areas identified by the BRAIN 2025, two general technology areas were identified to be appropriate for commercial development and are outlined below. While some of the markets for these products may be small, NIH is supportive of developing these technologies towards sustainable commercial manufacture.  This will enable novel hypothesis-driven experiments to understand the brain that are currently infeasible, or will reduce barriers to these experiments that currently are costly, difficult, or take too long to perform widely.  This FOA seeks to highlight two central themes for exploration: 1) Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative and 2) Developing novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function.

Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative.  This FOA seeks STTR phase I applications for proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of neural activity, to enable transformative understanding of dynamic signaling in the nervous system.  In particular we seek exceptionally creative approaches to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high risk, but if successful could profoundly change the course of neuroscience research.  

In addition, to achieve their potential these technologies must also be optimized through feedback from end-users in the context of the intended experimental use, and scalable manufacture platforms/processes developed to enable reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.  This FOA would also support STTR phase II applications for the iterative refinement and development of manufacture for emergent technologies and approaches that have already demonstrated their transformative potential through initial proof-of-concept testing in the phase I STTR or SBIR. 

Technologies may engage diverse types of signaling beyond neuronal electrical activity for large-scale analysis, and may utilize any modality such as optical, electrical, magnetic, acoustic or genetic recording/manipulation.  Applications that seek to integrate multiple approaches are encouraged.  Where appropriate, applications are encouraged to integrate multiple domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis. 

Examples of priority topics:

  • Probes for Large Scale Sensing and/or Manipulation of Neural Activity in Vivo
  • Imaging Instrumentation for Recording and/or Manipulating Neural Activity in Vivo
  • Development of Electrodes for Large-Scale Recording and/or Circuit Manipulation in Vivo
  • Techniques and Approaches for Recording/Manipulating Neural Activity during Behaviors

Development of novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function.  The new tools and technologies should confer a high degree of cell-type and/or circuit-level specificity.  Of particular interest for this FOA are first-in-class and/or cross-cutting non-invasive or minimally invasive techniques that permit repeated measurements from cells over time in a non-destructive manner.   Tools/technologies relevant for this initiative are expected to be transformative, either through the development of novel tools that may be high-risk or through major advances in current approaches that break through technical barriers and will significantly improve current capabilities. In addition, tools developed through this initiative that can be used in a number of species/model organisms rather than those restricted to a single species are also highly desired as are tools that can be used in any point in the lifespan.

To achieve their potential the utility of these tools/technologies must also be validated.  This FOA would also support STTR phase II applications for the validation and optimization of existing and emerging technologies and approaches. This includes the iterative refinement of emergent technologies and approaches that have already demonstrated their transformative potential through initial proof-of-concept testing in the phase I STTR or SBIR, with an end-goal of broad dissemination and incorporation into neuroscience labs. 

Examples of priority topics might include, but are not limited to:

  • Novel methods (non-genetic and genetic) to deliver active agents to specific neurons in particular neural circuits or brain areas with no or minimal cytotoxic effects.
  • Significantly improved viral-mediated gene delivery that targets specific cells or cell types in the nervous system.
  • Innovative ways to use multiple vectors to deliver "split" gene products to limit and/or control expression in specific cell types.
  • Novel, transgenic methods in multiple model species and across the lifespan to allow more refined cell-specific and circuit-specific manipulation.
  • Chemical or genetic engineering of BBB-crossing carrier agents (such as tagged antibodies) or other tools) to allow inclusion of specific cargoes (e.g., neuronal activity effectors or sensors)
  • Novel methods for non-invasive, targeted access to, or manipulation of, distinct cell types in defined circuits with spatio-temporal control
  • Novel trans-synaptic tracers that can work in retrograde and anterograde direction, or deliver cargoes to cells in the nervous system.
  • Enhanced temporal and spatial resolution techniques for noninvasive molecular imaging of neuronal cells for in situ brain studies.
  • Unique combinations of tools for multiplex analysis and/or manipulation of single cells in situ to maximize data content over many parameters (e.g., RNAs, proteins, metabolites, organelles, electrochemical dynamics, signal secretion/reception/transduction, cytoarchitecture or migratory changes).
  • Tools that provide significant advances in sensitivity, selectivity or spatiotemporal resolution of molecules/structures/activities within single cells in the brain and between ostensibly similar cells in situ (e.g., high resolution imaging of molecular interactions within single cells).
  • Novel automated and scalable assays for high-throughput analysis of single cells in situ in the brain, including scalability of measured parameters in parallel, cell numbers and/or speed of processing.
  • Systems-level single cell dataset analysis, including computational approaches, in the context of a functional circuit.
  • New tools and approaches that minimize tissue and cell perturbations so that cell viability is maintained, allowing for multiple repeated measures in the same cell over time.
  • Methods for tagging neurons to create identified cells.
  • Development of in situ sequencing using FISH and other sequencing methodologies.
  • Novel methods for visualizing epigenomic marks in neural cells.

Projects with non-exempt human subjects research, including clinical trials, are not included in this FOA. 

Section II. Award Information
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)
Renewal (Phase II)
Resubmission (Phase I, Phase II , Fast-Track)
Revisions (Phase I, Phase II, 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.

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.

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 must be less than 50 percent participation by foreign business entities in the joint venture;
  3.   
    1. 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
    2. 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
    3. 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. 

Foreign Institutions

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.

Required Registrations

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 RegistryNew 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

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.

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept 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 or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

  • Contractual/Consortium Arrangements

    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.

    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, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Page Limitations

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

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

    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.

    SF424(R&R) Senior/Key Person Profile Expanded

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

    R&R Budget

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

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy: This FOA is for both new technologies and/or novel approaches, as well as optimization of existing and emerging technologies. Because such projects are expected to be early-stage and potentially high-risk, preliminary data on feasibility are not required.  However, a sound rationale should be provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful, and emphasis should be placed in details of the approach, particularly feasibility-testing. 

    Although proposed technologies should enable or reduce major barriers to hypothesis-driven experiments, applications should focus on the technology rather than experimental or biological aims. Projects may engage in iterative development in the context of specific experiments, but these experiments should be formulated to validate the technology and demonstrate its capabilities, rather than advancing the state of biological knowledge.   Applicants are expected to explain the specific biological assay(s) to be utilized for validation.

    For optimization of existing and emerging technologies, applicants are strongly encouraged to follow standard engineering design principles in their applications.  These principles include solicitation of design requirements from end-users incorporating the context of the experiments to be enabled, and clear, quantifiable performance metrics that encompass as many aspects of the end-use experience as is feasible.

    It is anticipated that many projects will begin with a limited roll-out to selected user-groups to provide iterative feedback and further refine requirements in the context of conducting model experiments, as well as metric-driven validation of the technology in comparison to current best practices, where appropriate. As Phase II applications are expected to have demonstrated basic proof of concept for the technology prior to entry, innovation will in part be evaluated by having a clear, comprehensive, and credible path towards transitioning an emerging technology to broad and routine neuroscience practice.    Consequently, applications should outline strategy to develop the technology towards reliable, sustainable manufacture suitable for broad dissemination and integration into regular neuroscience practice.   Applications should include a plan for ongoing consultation with end users, relevant expert technologists, and where applicable, experts in appropriate manufacturing technologies for sustainable dissemination.  Named individuals from these groups who will serve as consultants for the project are encouraged.

    All applications should include the following:

    Current State-of-the-Art: Investigators should specifically define the current state of technology as a benchmark against which their proposed improvements will be measured. 

    Timeline and Milestones:  A timeline should be included as part of the Research Strategy and should include a distinct final section, entitled "Milestones," that briefly proposes indicators of progress at critical junctures. Milestones should be tailored to the unique scope of each project, and written concretely enough to evaluate what exactly will have been achieved during the course of the project.  Tests should include a comparison against existing benchmark technologies.  Investigators should briefly note how results will be used to inform future phases of development such as testing in other model systems.  

    Resource Sharing Plans: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) SBIR/STTR Application Guide, , with the following modification:

    • All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

    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, with the following modification:

    Note that Phase I SBIR/STTR Appendix materials are not permitted.

    3. Submission Dates and Times

    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.

    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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

    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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.  

    Section V. Application Review Information

    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.

    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.

    For this particular announcement, note the following:

    For Phase I applications, projects are expected to be early-stage and potentially high-risk; preliminary data on feasibility are not required.  However, a sound rationale should be provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful.  The research approach will be evaluated for logic and novelty. Although reviewers will consider feasibility, they will not penalize unavoidable risks that are intrinsic to new and innovative approaches.

    In contrast, Phase II applications are expected to focus on the optimization of existing and emerging technologies and the development of scalable manufacture platforms/processes to enable reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.   As proof of concept is required prior to Phase II, innovation will in part be evaluated by having a clear, comprehensive, and credible path towards transitioning an emerging technology to broad and routine neuroscience practice.

    Overall Impact

    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).

    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 II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

    Does the proposed technology represent a major improvement over current state-of-the-art? Will it serve to enable hypothesis-driven experiments that are currently infeasible, or reduce major barriers to experiments that currently are costly, difficult, or take too long to perform?   

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?     

    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?

    Is the overall plan for iterative development well staged, tractable and appropriately adaptive? Are initial design criteria proposed with clear and justifiable metrics for verification and validation? Were these initial design criteria developed through appropriate communication with end-users? Does the development plan include a convincing path towards a sustainable product for wide dissemination? 

    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?   

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

    Market, Customer, and Competition

    • Although the market may be small, how well has the applicant described the market niche(s) for the product/ technology, and how urgent is the unmet need(s) being addressed?
    • How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product?
    • To what extent has the applicant identified their customers and demonstrated a clear understanding of their needs?

    Company

    • How well can the applicant SBC sustain itself and grow as a business?
    • To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product/technology?
    • To what extent will the applicant's business alliances and/or corporate partnerships help in facilitating commercialization? For example, will third-party investors play an active role in facilitating the commercialization of the product/technology, and if so to what extent?
    • If the SBC has received previous SBIR/STTR funding from ANY Federal agency, then how successful is the company's track record in commercializing prior SBIR/STTR projects?
    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

    Not Applicable

    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

    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 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) /Genomic Data Sharing Plan.

    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) 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 submitted in response to this FOA. 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:

    • 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.
    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's business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    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.

    Report fraud, waste and abuse

    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

    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. When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    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 Part III. Section 5, "SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations," in the Supplement Grant Applications For All Competing Applications and Progress Reports.

    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.

    Application Submission Contacts

    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: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Telephone: 301-710-0267
    Email: GrantsInfo@nih.gov

    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
    Email: commons@od.nih.gov

    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

    Scientific/Research Contact(s)

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

    Bradley Wise, PhD
    National Institute on Aging (NIA)
    Telephone: 301-496-9350
    Email:  wiseb@nia.nih.gov

    Changhai Cui, PhD
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone:  301-443-1678
    Email:  changhai.cui@nih.gov

    Dr. Kathy Jung, PhD
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone:  301-443-8744
    Email:  jungma@mail.nih.gov

    Antonio Noronha, PhD
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-7722
    Email: anoronha@willco.niaaa.nih.gov

    Stephanie Fertig, MBA
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-1779
    Email: fertigs@ninds.nih.gov

    Roger Miller
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-402-3458
    Email: millerrnidcd.nih.gov

    Kristopher Bough
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-9800
    Email: boughk@nida.nih.gov

    Peer Review Contact(s)

    Joseph Rudolph
    Center of Scientific Review (CSR)
    Telephone: 301-408-9098
    Email: josephru@csr.nih.gov

    Financial/Grants Management Contact(s)

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

    Richard Proper
    National Institute of Aging (NIA)
    Telephone: 301-402-7735
    Email:properr@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone:  301-443-4704
    Email:  jfox@mail.nihl.gov

    Tijuanna DeCoster, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: decostert@mail.nih.gov

    Diana Haikalis
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-435-1373
    Email: dhaikali@nida.nih.gov

    Chris Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713
    Email: myersc@nidcd.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 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.

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