See the Glossary for more terms.
Table of Contents
Read the questions and answers below or see the Table of Contents above.
Find basic information on small business awards at our Small Business Awards page, which includes Advice Presentations for SBIR and STTR and our Small Business Innovation Research and Small Business Technology Transfer Grants SOP.
Submit your application through Grants.gov by scrolling down the SBIR funding opportunity announcement or the STTR funding opportunity announcement and selecting the button that says "Apply for Grants Electronically." NIH does not accept printed applications that use the PHS 398 for small business awards.
Remember to read the full announcement before beginning your application. Find more advice in the Strategy for NIH Funding and Advice Presentations for SBIR and STTR.
A small business is independently owned and operated and not dominant in its field. It has no more than 500 employees and it controls the facilities in which it conducts a major part of NIH-supported research. See the Basic Information module of Advice Presentations for SBIR and STTR.
You can obtain funding for a clinical trial, but not by applying for an SBIR or STTR grant (with the exception of our NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)). For the clinical trial part of your research, you must go through the NIAID investigator-initiated clinical trial process and apply for either an R34 (if you need a planning phase), R01 (if you are ready to begin a low-risk clinical trial), or U01 (high-risk clinical trial).
Talk with your program officer first about whether we can support your proposed clinical trial. Also, see our Investigator-Initiated Clinical Trials questions and answers.
For the non-clinical trial parts of your research you can apply for an SBIR or STTR grant. However, if your small business award becomes eligible for funding but includes a clinical trial, we will remove the clinical trial part, reduce your budget, and bar you from spending funds on a clinical trial.
Yes. You can pay for patent costs out of a fee that you request for your Small Business Innovation Research or Small Business Technology Transfer grant, but you cannot pay directly from grant funds.
Very important. Reviewers will give the Approach section of the Research Strategy the most weight when evaluating an application. Read more information in the Writing for Reviewers module of Advice Presentations for SBIR and STTR.
In general, grantees own the rights to data and inventions resulting from any grant-supported project. See the Basic Information module of Advice Presentations for SBIR and STTR for more information on how to handle intellectual property issues.
We strongly recommend that you acquire at least a provisional patent before you apply. See the Basic Information module of Advice Presentations for SBIR and STTR. Also read the NIH Grants Policy Statement for more information on intellectual property rights.
No. NIH may use march-in rights only if an awardee fails to achieve practical application of an invention. Furthermore, NIH has never exercised this right because of the lengthy administrative process. For more information, see Appendix D of the June 4, 1998, Report of the NIH Working Group on Research Tools.
You have one year to file a patent application. Read more about provisional patents in the Basic Information module of Advice Presentations for SBIR and STTR.
You may outsource up to 33 percent of your project for a phase I SBIR award or 50 percent for a phase II SBIR. For an STTR award, you may outsource up to 60 percent of your project.
While you may have some leeway with this requirement in an SBIR grant, the maximum outsource level for STTR grants is not negotiable.
The more you expand your application, the more likely you are to say something reviewers object to. Your best strategy is to limit your phase I goals to those necessary to support your phase II application. For more advice, see the Writing for Reviewers module of Advice Presentations for SBIR and STTR.
We don't see a difference in the success rates of applications submitted within normal guidelines and those requesting more time or more funds.
For applications that score within the fundable range, the most common reason for failing to get an award is not meeting just-in-time requirements. The Managing the NIH Timeline module of Advice Presentations for SBIR and STTR lists common reasons that a small business application does not receive a score within the fundable range.
Yes, if all of the following are true:
Read more in the Eligibility section of the parent announcements, SBIR Eligibility and STTR Eligibility.
Not directly. You may not spend funds outside the U.S., but your application can request and justify a fee of up to 7 percent of your total grant. Since fees belong to the company, you may use that money for costs outside the U.S.
You may not spend any STTR funds outside the U.S. unless you receive approval from the NIH Small Business Office. Obtaining this approval is usually a lengthy and unsuccessful process, so we don't recommend it.
Another option is to request a fee as stated in the question above.
You may use STTR funds to analyze samples from a foreign country, but the analysis must be performed in the U.S.
Yes, you can use your 7 percent fee to pay for consultants to file required reporting or administrative grant assistance. The fee is not a direct or indirect cost to the grant. Check out our Small Business Awards for more information.
To learn more about other award mechanisms that are open to small businesses, see slide 7 in the NIH Offers More Than SBIR and STTR Funds module in the Advice Presentations for SBIR and STTR.
Also search the NIAID Funding Opportunities List and contact other institutes. Note that you will face strong competition with funding opportunities that are open to large companies and academic investigators.
See Section 3 of the PHS 2590 Instructions and Section 5.4 of SBIR/STTR Application Guide SF 424 (R&R).
Your phase I progress report is included in the Research Strategy section of your phase II application. The Research Strategy has a 12-page limit, but the number of those pages you use for your progress report is up to you. It is also up to you whether to put your progress report in the Significance, Innovation, or Approach parts of the Research Strategy, or whether it would work better as a separate part.
If you are not submitting a phase II application, your final progress report has no page limits and must be submitted within 90 days of the termination of your phase I award. (Submitting a phase II application relieves you of this obligation.) If you do decide to submit a phase II application, you must fit your progress report into the phase II application's 12-page Research Strategy.
A university can be either a minority co-owner or a subcontractor. Keep in mind that funding for subcontracting is limited. See Providing Consent to Subcontract for more information.
An SBIR grant requires that a principal investigator be employed primarily by a small business. An STTR grant doesn't make that demand, but it does require that the grantee collaborate with a university or other nonprofit research institution.
For more differences, see the SBIR and STTR Comparison Chart and the Basic Information module of Advice Presentations for SBIR and STTR.
All NIH grants, including SBIR and STTR, are awarded to the PI's institution. If the PI moves to a new institution, both the original and new institution have to agree to transfer the grant and have prior approval from NIAID.
No, but if you get funded you can request and receive a fee of up to 7 percent of your total grant. You can use that for expenses not allowed in the grant budget, such as foreign consultants, marketing research, and patent applications.
Yes. Under this scenario the applicant would no longer be classified as a small business and therefore no longer eligible for an SBIR/STTR grant. The applicant should withdraw the application and could try to submit under a different mechanism.
Yes. For the Financial Questionnaire: Evaluation of Financial Management Systems, that is an accepted line of credit and counts toward your financial capability.
You can, and we recommend that you do. See the Basic Information module of Advice Presentations for SBIR and STTR.
Yes. See the Writing for Reviewers module of Advice Presentations for SBIR and STTR for an example.
Yes. The NIH Omnibus Solicitation is equivalent to an unsolicited application.
No. Once we award a phase I small business award, you cannot switch mechanisms.
No. According to the Omnibus Solicitation for SBIR/STTR Grant Applications, a company or subsidiary must have majority ownership by U.S. citizens and a principal place of business in the U.S. It must also conduct all grant-funded research in the U.S.
SBIR Fast-Track requires phase I and phase II applications in the initial application. In contrast, a normal SBIR application includes only phase I, and you send the phase II application only if a phase I award is made.
We do not recommend applying for a Fast-Track award. See the Basic Information module of Advice Presentations for SBIR and STTR for an explanation.
Because a Fast-Track application contains both phases I and II, people often think it saves a lot of time. However, a Fast-Track application typically requires four times more work than a phase I application. For more information, view the Basic Information module of Advice Presentations for SBIR and STTR.
See the Research Objectives section of the SBIR funding opportunity announcement for instructions on how to apply for the NIAID Advanced Technology SBIR (NIAID-AT-SBIR).
NIAID accepts applications for phase II renewal SBIR awards for projects that have made significant progress toward FDA approval. Phase II renewal applications may request a maximum of $1 million a year for up to three years.
We allow some flexibility in the SBIR 50 percent cap on consultant and contractual costs if you justify the expenditure. In your renewal application, respond to the additional review criteria listed in the Application Review Information section of NIH's SBIR-STTR Omnibus Solicitation.
NIAID does not have sufficient STTR funds to accept applications for STTR phase II renewals.
For more details, read the NIAID-AT-SBIR program announcement and our Small Business Awards page.
If your program officer approves, submit a late phase II application. Program officers may approve late submissions for projects that meet an NIAID priority and have a reasonably good chance of getting a fundable score.
Before you apply, you have to wait for your program officer to send NIH a special form. See Awaiting Receipt of Application SOP for more information.
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Last Updated June 11, 2014
Last Reviewed May 16, 2014