- What kinds of small business projects does NCATS support?
- How does NCATS support small businesses?
- My business may be a good candidate for NCATS support — what should I do next?
- What advice would you have for first-time applicants?
- What are the five systems I need to register for before submitting my application?
- How do we know which part of NIH to apply to if our technology touches multiple disease areas? Would my application be forwarded on to another NIH component if there is a better fit?
- How long does it take to get funding after submitting your application?
- What are the advantages of coding your application as a woman-owned small business or a socially and economically disadvantaged small business? Does this affect your chance of success?
- Can you provide guidance on transitioning from a Phase I award to applying for a Phase II grant?
- Is it possible to submit a Phase II proposal to NCATS if the Phase I was received from a different institute or agency?
- If an application is rejected, could you provide guidance on the pros/cons of doing a "resubmission" vs a "new proposal"?
- Does NCATS fund medical device development?
- Does NCATS fund clinical research or only pre-clinical research?
- Where can I get answers if I have more questions?
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are one of the largest sources of early-stage capital for technology commercialization in the United States. These programs allow US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. The SBIR program includes the following objectives: using small businesses to stimulate technological innovation; strengthening the role of small business in meeting federal R/R&D needs; increasing private sector commercialization of innovations developed through federal SBIR R&D; increasing small business participation in federal R/R&D; and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program.
NCATS works to increase small business participation in federally supported research and development as well as in private-sector commercialization of technology through its SBIR and STTR programs. Through these efforts, NCATS supports the development of clinical technology, instruments, devices and related methodologies that may have broad application to translational research and better patient care.
NCATS offers small business funding opportunities and access to resources to support commercialization strategies through two different mechanisms: grants and contracts.
- Grants include the annual SBIR/STTR Omnibus Solicitations for investigator-initiated applications, as well as targeted announcements designed to advance technologies in specific areas.
- Contracts are made available annually on specific topics covering a range of technology development. Find open small business funding opportunities.
NCATS has several programs that are also open to small businesses. They include the TRND program, which provides support for pre-clinical development of rare or neglected diseases, and the BrIDGs program, which assists researchers in advancing promising therapeutic agents through late-state pre-clinical development in preparation for an Investigational New Drug application.
NCATS supports research and development for a range of technologies, instruments, devices and related methodologies. To find out if your small business is the right fit for NCATS support:
- Ensure that your business or research institution meets the eligibility criteria.
- Review open funding opportunities for small businesses.
- Explore NCATS' small business research priorities.
- Contact NCATS to discuss your project and ask questions by emailing NCATS-SBIRSTTR@mail.nih.gov.
- Talk to an NCATS Program Officer. This is an important first step. Program Officers are subject-matter experts and will offer invaluable information about your application, including the relevance to NCATS’s mission and any technical submission questions you may have.
- Demonstrate the need and commercialization potential. Common reasons that applications don’t score well are:
- The proposed project is not significant. The application does not address a critical barrier to progress in the field or fails to make a scientifically convincing case for commercial potential or societal impact.
- The application has not provided an adequately defined test of feasibility.
- The proposed technology or therapeutic is not sufficiently innovative compared with available products on the market. Applicants should review published work and show how the project is different and better.
- The application’s research plan is diffuse, superficial or unfocused. Reviewers look for clear specific aims.
- The application did not fully demonstrate the expertise of the team, strategy or capacity for success.
- Start early. It can take between one and two months to complete all of the application requirements and registrations. You will need to register in five systems before you can submit your application. You can use NIH ASSIST, a program that will walk you through the entire application. Check out our fact sheet on what you need to do to apply.
- Dun and Bradstreet Universal Numbering System (DUNS). All registrations require a DUNS number before beginning the remaining registrations.
- System for Award Management (SAM.gov). This government website consolidates all business registrations in a government vendor database so that payments can be made more efficiently.
- Grants.gov. This portal lists all available federal grants and is used by all 26 federal grant-making agencies, including NIH.
- Electronic Research Administration (eRA Commons). This NIH system allows applicants, grantees and NIH staff to access, share and transmit their application and grant information. You can learn more about the top five errors people make when registering for this system.
- SBA Company Registry. You must attach proof of your SBA Company Registry to your SBIR/STTR application.
How do we know which part of NIH to apply to if our technology touches multiple disease areas? Would my application be forwarded on to another NIH component if there is a better fit?
We encourage applicants to review NCATS' SBIR & STTR research priorities to talk to us before submitting and application to ensure that it is a good fit. If it’s not within our research interests, we’ll recommend another part of NIH. Sometimes applications do span across various institutes. You can also list another NIH institute or center as a secondary assignment on your application. You can also review the NIH Program Descriptions and Topics document.
It generally takes about seven to nine months between application submission and announcement of the award if you are successful.
What are the advantages of coding your application as a woman-owned small business or a socially and economically disadvantaged small business? Does this affect your chance of success?
Although this information has no bearing on the success of your application, collecting this information allows us to know which segments of the population are applying and to design programs, resources and seminars to better serve these constituencies.
- Learn more about special designations.
- View a webinar on opportunities for women entrepreneurs and the SBIR and STTR
The grantee may submit a Phase II application either before or after expiration of the Phase I budget period. To maintain eligibility to seek Phase II support, a Phase I grantee should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period. If the grantee is outside of the receipt period timeframe, they must contact their Phase I Program Officer to determine if the Program Officer is willing to receive a late application. If so, a waiver may be granted.
Is it possible to submit a Phase II proposal to NCATS if the Phase I was received from a different institute or agency?
It is certainly possible to switch institutes or agencies when moving from Phase I to Phase II if the project direction warrants it. However, we recommend talking to program officers at NCATS and the other institute or agency before applying to ensure the next phase will still be a good fit. Contact NCATS to discuss your project and ask questions.
If an application is rejected, could you provide guidance on the pros/cons of doing a "resubmission" vs a "new proposal"?
For all phases, when submitting or re-submitting between an RFA and an investigator-initiated funding opportunity (PA, including the SBIR/STTR Omnibus solicitations, PAR, PAS) please review the guidance found in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html.
NCATS does not generally focus on medical devices. However, we still encourage you to contact the NCATS staff to determine if what you are proposing is an appropriate fit for the Center’s SBIR/STTR priorities.
NCATS will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. NIH defines a clinical trial as 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. See the Revised NIH Definition of “Clinical Trial” and Clinical Research Policy. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact NCATS-SBIRSTTR@mail.nih.gov before submission.
- If you have more questions about NCATS' SBIR and STTR programs, contact the Center's small business team for assistance.
- For general questions about SBIR and STTR at NIH, visit the Frequently Asked Questions (link is external) page on the NIH SBIR & STTR website.
- For more in-depth discussions of these topics, visit our archive of recent webinars.
If you have problems with your electronic submission, contact the Helpdesks for grants.gov and/or the eRA Commons: