Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs

About NCCIH’s Small Business Program

The National Center for Complementary and Integrative Health (NCCIH) offers two distinct funding mechanisms that advance small businesses:

  • The Small Business Innovation Research (SBIR) program
  • The Small Business Technology Transfer (STTR) program

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Together, these programs are known as America’s Seed Fund. The SBIR and STTR programs are one of the largest sources of early-stage capital for technology commercialization in the United States. Both programs allow U.S.-owned and -operated small businesses to engage in Federal research and development that has a strong potential for commercialization. The National Institutes of Health’s (NIH) SBIR and STTR programs invest over 1 billion dollars each year into health and life science companies that are creating innovative technologies that align with NIH’s mission to improve health and save lives. A key objective is to translate promising technologies to the private sector and enable lifesaving innovations to reach consumer markets.

We invite you to explore the NCCIH strategic plan to learn more about how your idea fits with NCCIH’s mission and priorities. Please also view a list of active funding announcements. Businesses interested in exploring SBIR/STTR grant opportunities with us are encouraged to contact the NCCIH small business team prior to submitting an application.

You can search for examples of projects currently funded by NCCIH by using NIH RePORTER.

Understanding the SBIR/ STTR Programs

Both the SBIR and STTR programs are divided into the three phases listed below. NIH has special Technical Assistance Programs to help small businesses move their technologies from the lab into the hands of customers. The NIH Niche Assistance Program and the I-Corps at NIH program are for Phase I awardees, and the NIH Commercialization Accelerator Program is for Phase II or Phase IIB awardees.

phase1

Phase I: Feasibility and Proof of Concept The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed research/research and development (R/R&D) efforts and to determine the quality of performance of the small business awardee organization prior to providing further Federal support in Phase II. Click on “See More” below to view NCCIH-Specific Budget and Duration Policies.

phase2

Phase II: Research/Research and Development The objective of Phase II is to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees are eligible for a Phase II award. Click on “See More” below to view NCCIH-Specific Budget and Duration Policies.

phase3

Phase III: Commercialization The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The NIH SBIR/STTR programs do not fund Phase III, and NIH does not generally provide any Phase III funding to small businesses.

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NIH also has a Fast-Track application that allows small businesses to submit one application for Phase I and Phase II, a Direct SBIR Phase II solicitation that permits small businesses to bypass a Phase I award if they have already proved the feasibility of their technology, and a Commercialization Readiness Pilot Program solicitation that can help support commercialization activities. For more information about which solicitation is best suited for your small business, view the Funding page and speak to the appropriate SBIR/STTR program manager.

NCCIH Participation in Fast-Track: NCCIH does not participate in the Fast-Track option through NCCIH-issued SBIR/STTR Funding Opportunity Announcements (FOAs). If interested in pursuing a Fast-Track option via the Omnibus solicitations, please contact a member of the NCCIH SBIR/STTR team.

As listed in NOT-AT-20-017, “NCCIH Policy Change to Budget Limit and Grant Durations for SBIR/STTR Phase I and Phase II Applications,” for budgetary, administrative or programmatic reasons, NCCIH may decide not to fund an application or may decrease the length of an award and/or the budget recommended by a review committee. 

Through this Notice, NCCIH has revised its budget and duration policies for SBIR/STTR Phase I and Phase II applications. Generally, NCCIH will not fund:

  • Phase I applications greater than $256,580 total costs for the duration of the project or project periods greater than 2 years.
  • Phase II applications greater than $1,710,531 total costs for the duration of the project or project periods greater than 3 years.

For “National Institutes of Health SBA-Approved SBIR/STTR Topics for Awards Over Statutory Budget Limitations,” the Small Business Administration (SBA) has approved an NIH SBIR/STTR Topic Waiver list for which NCCIH generally will not fund:

  • Phase I applications greater than $325,000 total costs per year or project periods greater than 2 years.
  • Phase II applications greater than $2,000,000 total costs for the duration of the project or project periods greater than 3 years.

SBIR and STTR Research Priorities

The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. The following narrative indicates the scope of projects suitable for the SBIR/STTR program that fit within the mission of NCCIH.

For additional information about areas of interest to NCCIH, please see the examples below, which were taken primarily from PHS 2020-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA (search the text for “NCCIH”) and NIH SBA-Approved SBIR/STTR Topics for Awards Over Statutory Budget Limitations

Examples of Topics

Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, special medicinal diets, and microbiome-/microbial-based therapeutics):

  • Development and validation of technologies for standardization and characterization of biologically active ingredients in natural products.
  • Development and validation of technologies for taxonomic identification of botanical raw materials or detection of adulterants.
  • Development and validation of technologies for the identification and characterization of bioactive metabolites derived from oral consumption of natural products.
  • Development and validation of methods for the sustainable production of low-yield natural products of commercial interest.
  • Development of novel analytical tools and technologies to study the microbiome, including its composition, genetics, and bioactivity, that can help clarify associations between the human microbiome and brain function and health.
  • Development of gut microbiome monitoring assays for validating safety and functional analysis of genomic and microbiota interactions.
  • Development of complementary and integrative therapeutic approaches to modify and balance the gut microbiota in healthy populations and individuals with disrupted microbiota and related diseases.
  • Clinical testing of natural products for the management of hard-to-treat symptoms such as pain, sleep disorders, or mild-to-moderate anxiety and depression to allow development of an evidence base that would accelerate U.S. Food and Drug Administration (FDA) approval of a drug indication for the natural product.

Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, tai chi, acupuncture, manual therapies, and music/art therapies):

  • Development, testing, and validation of appropriate objective and/or quantitative measures and instruments to assess or monitor mind and body approaches in different contexts (e.g., classrooms, families, child welfare, juvenile justice systems).
  • Development, testing, and validation of measures and tools to assess training or fidelity of implementation of mind and body approaches in different settings (e.g., health care, community, families, schools, child welfare, juvenile justice systems).
  • Development and testing of technologies for the implementation of mind and body approaches in group or individual settings and/or self-care strategies. Examples may include but are not limited to the use of mobile health technologies such as smartphone apps, sensors, online delivery, or phone-based delivery.
  • Development and validation of methods for standardization and characterization of the active components of mind and body approaches.
  • Development and validation of methods for standardization of multimodal interventions to study whole person health.
  • Development and validation of imaging tools or instruments for studying manual therapies, including but not limited to massage, acupuncture, or spinal manipulation.
  • Development and testing of innovative technologies for multisensory delivery of mind and body approaches.
  • Development, testing, and validation of innovative technologies to enhance sensory-based (temperature, light, olfaction, etc.) therapies.
  • Development, testing, and validation of innovative technologies to facilitate delivery of music/art-based interventions and to identify novel outcome measures and biomarkers for these interventions.

General Tool/Technology Development:

  • Development and validation of biomarkers that correlate with efficacy of complementary and integrative health approaches.
  • Development and validation of standardized, reliable, and cost-effective tools that correlate with brain imaging in response to mind and body interventions.
  • Development and validation of tools, technologies, and instruments, including gaming and virtual reality technologies, for the accurate assessment of adherence and/or fidelity to the use of mind and body practices and interventions.
  • Development and validation of tools to improve patient-reported outcome measures of importance in clinical studies of complementary and integrative health approaches.
  • Development, pilot testing, and validation of wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals for mind and body approaches.
  • Development or adaptation of biochemical or epigenetic monitoring devices for complementary and integrative health approaches.
  • Development and validation of tools to improve biological and physiological outcome measures for use in clinical studies of complementary or integrative health approaches.
  • Development or adaptation of technologies for objective assessment of pain with relevance to complementary and integrative health approaches.
  • Development of sleep monitoring technologies or biomarker panels to assess sleep deprivation, sleep deficiency, circadian rhythm dysregulation, and connection of sleep disturbances with health risks.
  • Development and testing of in vivo labeling technology of tissues or cells responsible for generating signals in response to different internal senses (e.g., mechanical force, temperature, osmolarity, oxygen levels).
  • Development and testing of technology or methods for quantifying biomechanical forces applied to internal tissues or cells.
  • Development and testing of mobile health technology or nonmobile technology and methods to monitor or quantify physical and/or emotional well-being, breathing, or sleep.

For information regarding FDA approval of a drug indication for a natural product, please see the FDA website for the Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER).

Resources for Technical Assistance

  • i-Corps at NIH—A competitive 8-week, hands-on program that provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology.
  • Applicant Assistance Program—A competitive, no-cost 10-week customized coaching program to help small businesses apply for Phase I SBIR/STTR funding.
  • Technical and Business Assistance Program—Helps small businesses identify and address product development needs.
  • NIH SBIR Resources—Discover the comprehensive suite of resources to help small businesses submit applications and commercialize their technologies.
  • NIH SBIR/STTR FAQs 
  • Draft Specific Aims—After you have decided the area of research to pursue, start thinking about your planned projects by first drafting objectives, known in NIH lingo as Specific Aims.
  • Sample Applications  

For applications involving clinical studies that fall within the NIH definition of a clinical trial, NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment used in clinical diagnosis of disease or monitoring of disease severity) of an intervention as a part of an SBIR/STTR Phase I application. Applicants seeking to conduct efficacy or effectiveness clinical trials should pursue funding via other FOAs such as the Omnibus SBIR/STTR Phase II, Direct to Phase II, and Fast-Track. See NOT-AT-19-012 for “NCCIH Policy for SBIR and STTR Phase I Applications Proposing Clinical Trials to the Omnibus Solicitations.”

For applications involving clinical studies that fall within the NIH definition of a clinical trial, NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment used in clinical diagnosis of disease or monitoring of disease severity) of an intervention as a part of an SBIR/STTR Phase I application. Applicants seeking to conduct efficacy or effectiveness clinical trials should pursue funding via other FOAs such as the Omnibus SBIR/STTR Phase II, Direct to Phase II, and Fast-Track.

Not sure if your research is a clinical trial? The NIH definition of a clinical trial is, “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” For additional information on NCCIH’s clinical trial policy, visit our Clinical Trials section.

Contact Information

Dr. Emrin Horgusluoglu, Program Director
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892 (Courier Service - 20817)

For general questions, refer to the NIH FAQs. Have a draft specific aims page ready? Please contact an NCCIH Program Director to determine programmatic fit.

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