Small Business Budget Information

Limited Amount of Award

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 $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%. Applicants considering a requested budget greater than $225,000 for Phase I and $1,500,000 for Phase II (total funding support) are strongly encouraged to contact Stephanie Fertig, Director, NINDS Small Business Programs at 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. Again, applicants considering a requested budget greater than these limits are strongly encouraged to contact program staff before submitting an application. For details see PHS 2015-2.

NINDS SBA-Approved SBIR/STTR Topics for Awards over Statutory Budget Limitations

The NINDS accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. Examples of research topics within the mission of NINDS are shown below. This list is not all inclusive and some research areas fall into multiple categories.

  1. Therapeutics and Diagnostics Development for Neurological Disorders, including biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for treatment of neurological disorders, and technologies/methodologies to deliver therapeutics to the nervous system.
  2. Clinical and Rehabilitation Tools, including intraoperative technologies for neurosurgeons, rehabilitation devices and programs for neurological disorders, and brain monitoring systems
  3. Technology and Tools, including technologies to image the nervous system, neural interfaces technologies, and tools for neuroscience research and drug development.

Within these research topics, the following research may require additional funds above the hard budget caps:

  1. In vivo animal testing required for therapeutics and diagnostics development.
  2. 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.
  3. 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.
  4. 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.
  5. In vivo animal testing of technologies for animal research and development of animal models for drug development and neuroscience research.
  6. Research that requires special facilities to contain hazardous or infectious materials.

Phase IIB Competing Renewal Awards

In addition to the traditional Phase I and II applications, NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies. These opportunities can be found on the NIH SBIR web page.

Clinical Trials

The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS will not accept unsolicited SBIR/STTR applications that include clinical trials under the Omnibus solicitation. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device interventions.

NINDS accepts and supports SBIR and STTR clinical trial applications through specific funding opportunities. Other human subjects research can also be submitted through the Omnibus solicitation. NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact Stephanie Fertig, Director, NINDS Small Business Programs at