Important note for current grantees: The "Project Outcomes" section of RPPRs will be made public
Average timeline from submission to award.
Determine Eligibility
Before submitting an application, determine whether you qualify for the NINDS Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) program. Please see NIH Small Business Eligibility Criteria.
Complete Registrations
Small businesses must complete required registrations before submitting an application, which can take six to eight weeks.
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Complete the required registrations as described on the NIH SEED Required Company Registrations page, and ensure your business has a valid Employer Identification Number.
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Additional resources to assist with registration may be found on the NIH Grants & Funding page for Organization Registrations and in Part I: Preparing to Apply of the How to Apply – Video Tutorials
Choose a Topic and Funding Opportunity
1. Please see Types of NINDS Small Business Grants for an outline of the differences between grants and contracts in the SBIR program.
2. Explore What We Fund to see if your topic is prioritized for program acceptance and to find assistance with your application from a subject matter expert.
3. For NINDS-specific information on funding support and research topics, see the NINDS section of the current Program Descriptions and Research Topics document for the SBIR and STTR Omnibus Grant Solicitations for the NIH, CDC, FDA, and ACF.
4. Review NINDS topics identified in recent SBIR Contracts. These topics generally align with specific NINDS Research Program priorities and may also be welcome as investigator-initiated proposals through the Omnibus Solicitations.
5. Browse NIH RePORTER and use the Matchmaker tool to find information on current projects approved for NIH funding, awarded project amounts, and competitors. Learn more at See Funded Projects and More Using NIH Databases.
6. Send a brief abstract or overview of the technology at least one month before the SBIR/STTR standard deadline to the NINDS Small Business Program Team for feedback regarding the scope and commercialization objectives for your proposed project.
7. After completing the steps above, select a funding opportunity. See the NIH SBIR/STTR Funding page. See a complete list of NOFOs that NINDS participates in at Funding Opportunities.
Develop a Budget
Applicants must follow the language and guidelines (including budget) in the specific program announcement to which they applied. Certain program announcements may have more limited budget guidelines than listed below. Applicants are encouraged to contact program staff with any budget questions prior to submitting an application.
For budgetary, administrative, or programmatic reasons, NINDS may decrease the length of an award and/or the budget recommended by a review committee, or not fund an application. According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed the below amounts.
The SBIR and STTR have different work requirements and levels of PI effort. Visit Types of Small Business Grants to learn more.
| Phase I | Total funding support (direct costs, indirect costs, fee) normally may not exceed $168,087, but can go up to $295,924 |
|---|---|
| Phase II | Total funding support (direct costs, indirect costs, fee) normally may not exceed $1,120,586, but can go up to $1,972,828 |
Applicants considering a requested budget greater than $295,924 for Phase I and $1,972,828 for Phase II (total funding support) are strongly encouraged to contact NINDS SBIR/STTR program staff at least a month before submitting an application.
NIH has received a waiver from SBA to exceed the hard cap for specific topics; absolute funding restrictions are listed in the table. A list of the NINDS wavier topics is shown below. NINDS SBIR/STTR Funding Opportunities that support budgets exceeding these guidelines clearly state additional budget guidance in the NOFO language. Note that NINDS does not provide prior approval of a budget waiver to applicants.
| Total Funding | Maximum Funding/Year | Duration (months) | |
|---|---|---|---|
| Phase I | $700K | $500K | 6 -24 |
| Phase II | $3M | $1.5M | 12-36 |
NINDS SBA-Approved SBIR/STTR Topics for Awards over Statutory Budget Limitations
The following research may require additional funds above the hard budget caps:
- In vivo animal testing required for therapeutics and diagnostics development.
- Drug and biologics preclinical discovery and development activities for regulatory submission, such as lead identification/optimization, preclinical efficacy testing, IND-enabling studies, and manufacturing for clinical trials.
- Device preclinical discovery and development activities for regulatory submission, such as hardware prototyping, device/software verification, biocompatibility/sterilization testing, pre-clinical efficacy testing, large animal GLP safety testing, and preparing material/devices for human testing.
- Clinical testing of therapeutics (drugs, devices, or biologics), diagnostics, clinical and rehabilitation tools (i.e. intraoperative technologies, rehabilitation devices and programs, and brain monitoring systems), and technologies for clinical research. This would include clinical research studies to test scientific hypothesis that are not feasible or practical to conduct in animal models but would inform a final device design.
- In vivo animal testing of technologies for animal research and development of animal models for drug development and neuroscience research.
- Research that requires special facilities to contain hazardous or infectious materials.
- Development and validation of biomarkers and the technologies and approaches for measuring them. Biomarkers may include diagnostic, prognostic, monitoring, pharmacodynamic/response, risk, safety, and predictive biomarkers.
In addition, several technology areas specifically associated with the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® , a Presidential project aimed at revolutionizing our understanding of the human brain, have been identified as appropriate for commercial development and may require additional funds above the hard budget caps:
- Development of research tools and technologies to understand the dynamic activity of neural circuits.
- Development of novel tools and technologies to facilitate the detailed analysis of complex circuits to provide insights into cellular interactions that underlie brain function.
- Development of invasive and non-invasive devices for recording and modulation in the human central nervous system.
Submit Your Application
Special Instructions for SBIR/STTR Applications
Pay close attention to Application Guide items marked “Additional Instructions for SBIR/STTR:” to ensure you submit a responsive application. Commercialization Readiness Pilot (CRP) Program applicants should note that Section IV of the CRP notice of funding opportunity contains extensive changes/additions to the standard instructions.
After identifying an opportunity, find information on writing a strong application by using the other sections of this website. Start at Preparing an Application.
Read the full notice of funding opportunity for detailed instructions before beginning your application. Download the SBIR/STTR Application Guide to use as a reference during the grant application process.
Your organization must submit SBIR and STTR grant applications electronically. Use NIH Application Submission System and Interface for Submission Tracking (ASSIST) or another of the NIH Submission Options. See NIH's How to Submit, Track, and View Your Application.
After Application
Learn the next steps for your application on the SEED website in After you Apply.
Learn about the NINDS SBIR/STTR Program Funding Plan.
Once awarded, visit Manage Your Award, which covers reporting requirements and much more and the SEED website Support for Small Businesses.
If a legal action occurs—such as a merger, acquisition, or successor-in-interest—that changes your organization status so that it is no longer eligible for the SBIR/STTR programs, existing SBIR/STTR awards cannot be awarded additional funds. Your organization would also no longer be eligible for any new SBIR/STTR grants.
Contact the NIH awarding office in advance of legal actions that may affect organizational eligibility. For more information, refer to the NIH Grant Policy Statement, Section 8.1.2.8 Change in Recipient Organizational Status. NIH will negotiate bi-lateral terminations with recipients that are ineligible to continue to receive SBIR/STTR funding.
NINDS Small Business Program Contact Information
Sign up for the Division of Translational Research Listserv to stay up to date with the latest news and funding opportunities!
Emily Caporello, Ph.D. Director emily.caporello@nih.gov Annette Gilchrist, Ph.D. Program Director, Drug Development annette.gilchrist@nih.gov Jessica Forbes, Ph.D. Health Program Specialist jessica.forbes@nih.gov Taryn Aubrecht, Ph.D. Program Director, Clinical and Research Tools taryn.aubrecht@nih.gov Sara Dauber, MBA Strategic Consultant sara.dauber@nih.gov