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 $168,087 for Phase I awards and $1,120,586 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts. Applicants considering a requested budget greater than $275,766 for Phase I and $1,883,436 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. A list of the NINDS topics is shown below. Generally, NINDS does not fund Phase I applications greater than $700,000 total funding support, with no more than $500,000 total cost in any year or project periods greater than 2 years. In addition, the NINDS does not generally fund Phase II applications greater than $3,000,000 total funding support, with no more than $1,500,000 total cost in any year, or project periods greater than 3 years. NINDS SBIR/STTR Funding Opportunities that support budgets exceeding these guidelines clearly state additional budget guidance in the FOA language. Note that NINDS does not provide prior approval of a budget waiver to applicants. Applicants considering a requested budget greater than these limits are strongly encouraged to contact program staff at least a month before submitting an application.
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.
Resources and Tools
We advise potential applicants to send us a brief abstract or overview of their technology at least one month before the SBIR/STTR standard deadline
Sign up for the Division of Translational Research Listserv