About NCCIH’s Small Business Program and Priorities
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. In Fiscal Year 2018, the National Institutes of Health’s (NIH) SBIR and STTR programs will invest over 1 billion dollars 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 RePORTER.
Understanding the SBIR/ STTR Program
Both the SBIR and STTR programs are divided into 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.
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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. *See NCCIH-specific Budget and Duration Policies (click on 'See more'). | |
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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. *See NCCIH-specific Budget and Duration Policies (click on 'See more'). | |
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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-19-014, “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 $225,000 total costs for the duration of the project or project periods greater than 2 years
- Phase II applications greater than $1,500,000 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 the NCCIH generally will not fund:
- Phase I applications greater than $325,000 total costs for the duration of the project 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 that were taken primarily from PHS 2019-2 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 NCCIH Non-Clinical Trials Topics
Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, or special medicinal diets)
- 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
- Clinical testing of natural products for the management of hard to treat symptoms such as pain, sleep disorders, or mild to moderate depression to allow development of an evidence base that would lead to FDA approval of a drug indication for the natural product
- 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 the brain
- Development of gut microbiome monitoring assays for validating safety and functional analysis of genomic and microbiota interactions
Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, Tai chi, acupuncture, manual therapies, music/art interventions, etc.)
- 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 etc.)
- 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., healthcare, community, families, schools, child welfare, juvenile justice)
- Development and testing of technologies for the implementation of mind and body approaches in group or individual settings. Examples include the use of mobile health technologies such as smart phone apps, sensors, on-line delivery, phone-based delivery, etc.
- Development and validation of methods for standardization and characterization of the active components of mind and body approaches
- Development and validation of technical imaging tools or instruments for studying manual therapies including but not limited to massage, acupuncture, or spinal manipulation
General Tool/Technology Development
- Development and validation of biomarkers which correlate with efficacy of complementary and integrative health approaches
- Development and validation of standardized, reliable and economical tools that correlate with brain imaging in response to mind and body interventions
- Development and validation of tools, technology and instruments, including gaming technology, for the accurate assessment of adherence and/or fidelity to the use of mind and body practices, interventions, and natural products
- Development and validation of tools to improve patient-reported outcome measures of importance in clinical studies of complementary and integrative health approaches
- Development, pilot test, and validate wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals for mind and body approaches
- Development or adaption of biochemical or epigenetic monitoring devices for complementary 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
Examples of NCCIH Clinical Trials Topics
Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, or special medicinal diets)
*For information regarding FDA approval of a drug indication for a natural product, please see the FDA website for Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER).
- Development and validation of technologies for standardization and characterization of biologically active ingredients in natural products
- Clinical testing of natural products for the management of hard to treat symptoms such as pain, sleep disorders, or mild to moderate depression to allow development of an evidence base that would lead to FDA approval of a drug indication for the natural product
- Development and validation of technologies for the identification and characterization of bioactive metabolites derived from oral consumption of natural products
- 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 the brain
- Development of gut microbiome monitoring assays for validating safety and functional analysis of genomic and microbiota interactions
Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, Tai chi, acupuncture, manual therapies, music/art interventions, etc.)
- Development, testing, and validation of appropriate objective and/or quantitative measures and instruments to assess or monitor mind and body approaches
- 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., healthcare, community, families, schools, child welfare, juvenile justice)
- Development and testing of technologies for the implementation of mind and body approaches in group or individual settings. Examples include the use of mobile health technologies such as smart phone apps, sensors, on-line delivery, phone-based delivery, etc.
- Development and validation of methods for standardization and characterization of the active components of mind and body approaches
- Development and validation of technical imaging tools or instruments for studying manual therapies including but not limited to massage, acupuncture, or spinal manipulation
General Tool/Technology Development
- Development and validation of biomarkers which correlate with efficacy of complementary and integrative health approaches
- Development and validation of standardized, reliable and economical tools that correlate with brain imaging in response to mind and body interventions
- Development and validation of tools, technology and instruments, including gaming technology, for the accurate assessment of adherence and/or fidelity to the use of mind and body practices, interventions, and natural products
- Development and validation of tools to improve patient-reported outcome measures of importance in clinical studies of complementary and integrative health approaches
- Development, pilot test, and validate wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals for mind and body approaches
- Development or adaption of biochemical or epigenetic monitoring devices for complementary 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
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 SBIR/STTR Phase I application. Applicants seeking to conduct efficacy or effectiveness clinical trials should pursue funding via other Funding Opportunity Announcements (FOAs) such as the Omnibus SBIR/STTR 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.
NCCIH Blog Posts on SBIR/STTR
- Changes to SBIR-STTR Programs are Here (June 28, 2019)
- Tips for Small Business Grant Applicants Considering NCCIH (August 14, 2019)
- NCCIH's SBIR/STTR Programs: Funding Small Business Research and Development (February 20, 2018)
Contact Information
Merav Sabri, Ph.D.
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)
merav.sabri@nih.gov
301-496-2583
Merav Sabri, Ph.D., joined NCCIH as a program director in 2017. She oversees and develops a portfolio with a focus on mechanistic studies of manual therapies (e.g., massage, spinal manipulation, joint/spine mobilization, and connective tissue stimulation) as well as the development of technologies and methods to monitor or enhance mind and body interventions through small business funding mechanisms. Dr. Sabri’s role with the Small Business program is to advise applicants about the alignment of their project with NCCIH’s mission/announcements and provide feedback on their Specific Aims page. Dr. Sabri is also instrumental in identifying next steps for applicants after an application has been reviewed.
Anastasia Solis
Program Analyst
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
6707 Democracy Boulevard II, Suite 401
Bethesda, MD 20892
(Courier Service - 20817)
anastasia.solis@nih.gov
301-594-8018
Anastasia Solis joined the NCCIH Division of Extramural Research in 2017 as a program analyst. Her role with the Small Business Program is working with potential NCCIH applicants through the first critical steps in applying for a Small Business grant. Her work involves identifying eligibility and alignment with NCCIH’s strategic plan and developing a Specific Aims page. Ms. Solis generally works with applicants prior to application submission.
Subscribe to our NCCIH SBIR Listserv
For updates about the NCCIH SBIR/STTR Program, send an e-mail with “subscribe NCCIH-SBIR your name” to NCCIH-SBIR@LIST.NIH.GOV