U.S. Department of Health and Human Services

Small Business Frequently Asked Questions

Here we answer Frequently Asked Questions posed to NIDDK Program Staff. For additional FAQs, please see the NIH-wide SBIR/STTR Program FAQs page.


NIDDK General Funding Information

In what areas of research is NIDDK interested?

​The NIDDK welcomes SBIR and STTR applications from small businesses in any biomedical or behavioral research area that falls within our mission. A sampling of areas of interest are described in the annual omnibus solicitation (PDF, 1.36 MB); this is not a comprehensive list.

What SBIR/STTR research is NIDDK “looking for”?

Each year the NIH publishes an omnibus solicitation (SBIR: PA-14-071, STTR: PA-14-072) that includes the areas of interest of each Institute; however, these are not comprehensive. In addition, the NIDDK has a list of active FOAS within our mission, but mostly it funds investigator-initiated research.  We are interested in all meritorious projects that are innovative and novel.

What is the difference between an SBIR and an STTR?

​The Principal Investigator on an SBIR grant must have his/her primary employment (>51 percent) with the small business; STTR applicants are REQUIRED to have a formal collaborative relationship with a research institution in the performance of the project that will lead to a commercial product. For more information check your Small Business Eligibility.

How does the NIDDK decide which SBIRs or STTRs to fund?

The NIDDK does not set an SBIR/STTR payline.  Funding decisions are based on a number of factors, including scientific area and portfolio need, score and proposal issues, and of course, budgetary availability.

How can I find out about SBIR/STTR-related information?

​By subscribing to the NIH listserv for small business-related information (SBIR/STTR LISTSERV), you will receive all updates as they are issued.

Are there limits on costs and length of time the project can last?

Small Business Innovation Research (SBIR) (R43/44)

  • Phase I:  Awards normally may not exceed $150,000 for DC, F&A, and fee for a period normally not to exceed one year.  May exceed this level.
  • Phase II:  Awards normally may not exceed $1,000,000 for DC, F&A, and fee for a period normally not to exceed 2 years.  May exceed this level.

Small Business Technology Transfer Program (STTR) (R41/R42)

  • Phase I:  Awards normally may not exceed $150,000 for DC, F&A, and fee for a period normally not to exceed one year.  May exceed this level.
  • Phase II:  Awards normally may not exceed $1,000,000 for DC, F&A, and fee for a period normally not to exceed 2 years.  May exceed this level.

What is the SF424 form (R&R)?

  • The SF424 Research and Research-Related (R&R) application form was developed for all federal agencies involved in research and research-related grant funding.
  • Grants.gov provides a single interface for all agencies to announce their grant opportunities and for all grant applicants to find and apply for those opportunities.

What is the Commercialization Assessment Program (CAP)?

The CAP is a program, consisting of training workshops, individual mentoring and consulting sessions for Phase II awardees, designed to help some of the nation’s most promising life science startups develop their commercial business. See the NIH CAP page for more information. Phase I awardees may apply for the Niche Assessment Program (NAP). See the NIH NAP page for more information.

Application process

How do I apply?

  • An overview of the SBIR/STTR Application Process is provided at the NIH-wide SBIR/STTR Program site.​
  • As of the April 5, 2009 receipt date, SBIR/STTR applications must be submitted using Adobe-based forms. For additional details, see NOT-OD-08-117​. All applications must be submitted electronically on the SF424 (R&R) via grants.gov.
  • For application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date. For additional details, see NOT-OD-14-074.
  • For questions specific to your proposed research project, please contact the NIDDK staff​.

If I can’t find an FOA to match my research area, what do I do?

You can use the "parent" or omnibus PA (SBIR: PA-14-071, STTR: PA-14-072), which is updated each year and can be accessed at the NIH-wide SBIR/STTR Program site.

Does my application compete with other NIH programs for funding?

​No. The funds for this program are 'set-aside' and therefore do not compete with the regular research, training, or other special programs supported by the Institute. The SBIR set-aside is 2.8 percent of the budget in FY 2014; The STTR program has an annual set-aside of 0.40 percent in FY 2014.

How do I know if the NIDDK will accept my application?

​You apply to the NIH, not individual Institutes, so you need not worry about where the application will go.  The Center for Scientific Research (CSR) accepts applications and makes assignments to all relevant Institutes, and hence, they determine which Institute is the most relevant.  The reviews of all applications are done by that office as well.

Do I need to have intellectual property (IP) on my technology if I apply for a grant?

​The NIH has no authority or official rules on IP.  That is the responsibility of the SBC, and not an NIH matter.  Similarly, the NIH has no control of or partnerships with states.  You need to investigate and follow local and state rules.

How can I find out if a similar technology to mine is being developed by someone else?

​The NIH RePORTER​ will enable you to find what has been NIDDK/NIH funded. You may also search the United States Patent and Trademark Office (USPTO) patent database to see if a patent has already been filed or granted that is similar to your technology.

Is there special consideration at NIDDK for matching funds (e.g., from states)?

​No. There is value to the applicant, but it is not part of the evaluation.

Can I track my application throughout the NIH process?

​Yes. eRA Commons allows you access to your application(s) at all phases of the process and funded grant status post award.

Company Applications & Awards

My company is majority owned by a venture capital (VC) group. Can I apply for an SBIR?

No.  Only companies with more than 50 percent ownership by multiple VCs (hedge funds, private equity firms, or any combination of these) are eligible to apply.  No single VC operating company, hedge fund, or private equity firm may own more than 50 percent of the small business concern (SBC).  VC-backed companies cannot apply for an STTR.

Are there any additional actions I have to take if my company is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms?

​Yes.  Prior to applying, download and complete the “SBIR Application VCOC Certification.pdf​” (PDF, 139KB) at the NIH Forms & Applications page.  Follow the instructions and submit the Certification with your application as instructed in the SBIR/STTR Application Guide.

Do SBIR/STTR companies have to submit and report any publications in the official NIH way?

Yes.  All publications that come out of NIH-funded research must have a PMCID. More information regarding the NIH Public Access Policy is available.

I have recently left my position at the small business, and therefore can no longer serve as the company PI and administrative contact for an SBIR grant. What is the procedure for changing these roles on this grant for the folks at my former company? 

​We need a letter from your former company, co-signed by the new Signing Official (SO) and you (if possible), detailing the changes and the request for a new co-PI (if applicable) with the CV of that person for our consideration and approval.  It is the company’s responsibility to update NIH via your company's eRA Commons​ account as well.

Where can I find information about financial management system requirements?

​Financial management system requirements for grantee organizations of the NIH are now addressed in the NIH Grants Policy Statement (NIHGPS) and Title 45 of the Code of Federal Regulations (CFR) Part 74.21. For links and more information, please visit the NIH-wide SBIR site's Financial Questionnaire: Evaluation of Financial Management Systems.

Phase I and Phase II

Am I permitted to submit a Phase II application if I have not yet received my Phase I award?

Yes. As of January 27th 2015, NIDDK is participating in the Funding Opportunity Announcement (FOA) PAR-14-088 "Direct Phase II SBIR Grants to Support Biomedical Technology Development (SBIR R44)" (See NOT-DK-15-006). If your small business has already completed R&D that is characteristic of a Phase I SBIR project, demonstrating scientific and technical merit and feasibility, you can apply for a Direct Phase II SBIR.

Is there a way to get funded for Phase I and Phase II at the same time?

​Yes. A Fast-Track allows the submission and review of Phase I and II applications at the same time.

I estimate that my feasibility study (Phase I) will cost $300k. Is that okay?

​No.  Per new rules, SBIR/STTR awards will be capped at 50 percent over the $150,000 and $1,000,000 allowance amounts for Phase I and II, respectively.  If a project you propose for Phase I will cost more than $225,000, you should reconsider the work proposed and reduce it; or, if you are considered for an award after review, you will have to make changes to be approved by NIDDK staff prior to funding to meet the requirement.  As you must justify all costs, we expect the amounts will be actual, not random.  You should request whatever length of time you'll need to complete the proposed work.

Another IC funded Phases I and II of my SBIR, but that Institute doesn’t participate in the Phase IIB program. Will the NIDDK accept it?

​As per the Omnibus Solicitation, the NIDDK only accepts Phase IIB applications for NIDDK-funded Phase I/II projects.

Is it possible to change companies and or PIs from Phase I to Phase II? 

It is possible.  We’re aware that small businesses don’t always make it, but the science and people behind it can!  For a company change, the NIDDK needs the official documentation of a name change or relinquishing statement from your company.  You can form company B and submit the Phase II application with a letter in the application explaining the change of company.

A change in PI can be done at any time, within or between funding cycles.  The NIDDK requires the request be co-signed by the SO and the PI and include the new PI’s CV and statement about level of effort on the award.

Application Scores

My application received a score that doesn’t match the individual scores of the reviewers. Why?

For helpful information on the NIH review and scoring system, go to Enhancing Peer Review at NIH or Peer Review Process​.

My application was reviewed and I have a score, but how can I find out more information?

The Summary Statement (SS), which will be released into your eRA commons account, will give you some insight as to the issues reviewers had with the application.  If the SS notes issues that are easily “fixed” by you, then amending the application will be easy.  There may be more difficult issues noted, but be aware that you don’t have to agree with all reviewer comments; you need only address them in the beginning of the amended application. For more information on resubmissions, please see Frequently Asked Questions, Resubmissions of NIH Applications.

My application score is “ND.” Was my application reviewed?

Unfortunately, the application was “not discussed.” While it was reviewed, and you will get a SS, it was in the lower 50 percent of the applications at that study section, so it was not discussed (an NIH rule). The scientific review officer will release the SS within 6 weeks, so you will be able to read the reviewers’ comments.  You do have the option of revising and resubmitting.

Changes to Award

Can I take my SBIR or STTR grant with me if I move?

Awards are issued to the small business, not the PI. If the business that holds the award is unable or unwilling to do the research without you, and you are moving to another eligible small company, it is possible to move the grant.  The NIDDK considers such situations on a case-by-case basis.

My spouse got a great job out of the country. Can I do the research funded by the NIDDK there?

​No. The research was proposed and funded to be conducted in the United States.  As per the NIH grants policy statement, "For both Phases I and II SBIR/STTR awards, the research project activity must be performed in its entirety in the United States.  In those rare instances where the study design requires use of a foreign site (e.g., to conduct testing of specific patient populations), the investigator must provide compelling scientific justification in the application for the need/use of a foreign site.  Similarly, in those rare instances where it may be necessary to purchase materials from other countries, investigators must thoroughly justify the request."  The NIDDK will consider these instances on a case-by-case basis.

I am in the final year of my SBIR funding and need supplemental funds to complete the aims. Is there a way to make such a request to the NIDDK?

You may request an administrative supplement for a small amount of funds to perform/complete work within the scope of the originally funded project.  We require a number of items to consider the request, including budget (submitted on official budget page), rationale/justification, funds remaining, and timeline for use of the funds requested.
As part of the initiative to make all applications electronic and to filter all applications through Grants.gov, the NIH has issued an FOA for administrative supplements (see PA-14-077).
A competitive supplement is for greater dollars, reviewed by the CSR, and may expand the scope/aims of the original grant.  You must submit the request like a full grant application using the SF424 (R&R).  Download the SBIR/STTR Application Guide.  See Section 2.8 "Revision" Application (formerly called a competing supplement).
The NIDDK's guidance regarding administrative supplement applications is available on the NIDDK website (see Administrative Supplements to Research Grants).

Can I move money that was funded for travel to the salaries category so that I can have an employee have more effort?

Per NIH rules, you are allowed to move up to 25 percent of funds from one budget category to another without NIDDK approvals.  In some cases, you may want to move more or all funds in one category to another; in that case, the NIDDK requires that you forward a letter with the details and have it signed by your signing official (SO) for us to review and approve officially.

I am on a no-cost extension (NCE) on my NIDDK STTR, but anticipate needing another 8 months beyond that to complete the technology research. What can I do?

The NIDDK allows the possibility of a second NCE for its SBIR/STTR awardees.  In order to consider your request for a second NCE, we need a letter co-signed by the PI and SO, with a detailed budget (on an NIH budget page), a detailed progress/status update, a detailed justification for the request, and the amount of unspent funds.