Last year, I informed you on this blog about the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America’s Seed Fund. These programs award competitive grants to eligible U.S. small businesses to support research and development of products or services intended to improve public health, having strong potential for commercialization. Today, I would like to update you on some important recent changes to these programs.
The first change is an update of NCCIH's high-priority topics of interest to include the following:
- Development and validation of biomarkers that correlate with efficacy of complementary health approaches
- Formulation, development, and clinical testing of natural products* that would permit U.S. Food and Drug Administration approval of a natural product for a specific indication
- Identification and validation of biological targets associated with complementary health approaches
- Development of innovative technologies and methods that facilitate new advances in natural products research
- Studies of the mechanistic effects of mind and body approaches** that will allow for optimization of the efficacy and safety of the mind and body approach for commercialization
- Nontraditional phenotypic assay development for complex natural product mixtures
- Integrated in silico tools for exploiting natural product bioactivity
- Development and clinical testing of innovative technologies and methods for mind and body approaches—for example, mobile health technologies such as apps, sensors, on-line delivery, and phone-based delivery
- Design, development, evaluation, and validation of devices or systems related to complementary health approaches.
*Natural products include botanicals, herbs, probiotics, prebiotics, dietary supplements, or special medicinal diets.
**Mind and body approaches include meditation, mindfulness, hypnosis, yoga, tai chi, acupuncture, manual therapies, and art and music interventions.
In addition, we have updated our Clinical and Non-Clinical Trials Topics of Interest (please view pages 171-173 of the Omnibus Solicitation for SBIR and STTR grants).
Second, NCCIH's budget and duration guidelines policy has changed (NOT-AT-19-104).
- If you are applying for Phase I, the proposed duration can be up to 2 years, and the budget can be up to $225,000 in total costs.
- If you are applying for Phase II, the proposed duration can be up to 3 years, and the budget can be up to $1.5 million in total costs.
Budget and duration for topics in the waiver list
- If you are applying for Phase I, the proposed duration can be up to 2 years, and the budget can be up to $325,000 in total costs.
- If you are applying for Phase II, the proposed duration can be up to 3 years, and the budget can be up to $2 million in total costs.
Third, we would like to clarify that NCCIH will not support clinical trials in Phase I that fall within the National Institutes of Health (NIH) definition of a clinical trial and are to test an intervention’s efficacy and/or effectiveness1 (NOT-AT-19-02).
I remain enthusiastic about the vast opportunities provided in our SBIR/STTR programs. If you’re interested in applying, I encourage you to:
- Consult NCCIH’s SBIR/STTR and NIH's SBIR/STTR web pages.
- Reach out to me for guidance at least 4 to 6 months before you submit an application.
- 1That is, the study is powered on a primary outcome that is a clinical assessment used in clinical diagnosis of disease or monitoring of disease severity. Alternatives include the Omnibus SBIR/STTR Phase II and Fast-Track.
- 2https://public.csr.nih.gov/StudySections; https://grants.nih.gov/grants/grants_process.htm