SBIR/STTR Application Process Infographic
Use this interactive chart that contains helpful information to guide you through the NIH SBIR/STTR application process. Click though the chart for answers to your related questions.
Confirm Your Small Business Meets Eligibility Requirements
Confirm Your Small Business Concern Meets Eligibility Requirements
View the eligibility requirements by visiting the SBIR/STTR eligibility criteria webpage.
Develop an Innovative Research Idea
Develop an Innovative Research Idea
Have a ground breaking idea that can be commercialized? HHS can provide funding for your technology idea!
The Omnibus SBIR and STTR solicitations allow small businesses to propose technologies focused on health, life-science or medicine to HHS for funding consideration. Be sure to speak with an HHS SBIR/STTR program manager BEFORE submitting an application. Program managers will discuss the Institute or Center (IC)’s interest in the proposed technology and can offer application-specific advice.
Also, check to see if one of the ICs has issued a targeted SBIR/STTR solicitation about your research topic.
Five Required Registrations: (Overview)
Five Required Registrations:
The registration process alone may take 6 – 8 weeks, so it’s important to START EARLY! All registrations must be completed prior to the application being submitted.
Registration and application instructions are found in the SF424 (R&R) SBIR/STTR Application Guide (Version D). Also, check out the Annotated SF424 (R&R) SBIR/STTR Form Set (FORMS-D) to guide you through the submission process.
**An error-free application in Grants.gov DOES NOT guarantee an error-free application in eRA Commons, since eRA Commons has HHS-specific application requirements that do not apply to Grants.gov**
Please contact the eRA service desk if you have problems:
Toll-free: 1-866-504-9552
Phone: 301-402-7469
Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (Except for federal holidays)
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Employer Identification Number (EIN) – The NIH requires both the EIN and a DUNS number prior to the issuance of a funding award. The EIN base for the organization is the IRS Tax ID number, for individuals it is their social security number, both of which are nine-digit numbers.
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Dun and Bradstreet Universal Numbering System (DUNS) – All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin SAM, SBA Company, and eRA Commons registrations.
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System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration.
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Grants.gov – Grants.gov is a federal-wide portal to find and apply for federal grant funding. It is used by all 26 federal grant-making agencies.
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eRA Commons – eRA Commons is NIH’s Electronic Research Administration system that allows applicants, grantees, and NIH staff to access, share and transmit application/grant information.
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SBA Company Registry – All applicants are required to register at the SBA Company Registry prior to application submission and attach proof of registration to their application.
SBIR Omnnibus (PA-20-260 non-CT, PA-20-262 CT)
STTR Omnibus (PA-20-265 non-CT, PA-20-261 CT)
SBIR Criteria:
Principal Investigator: Must be employed by the small business
Research Partner: Research partner optional, total effort up to 33% for Phase I and 50% for Phase II
STTR Criteria:
Principal Investigator: Can be employed by the small business or a non-profit research institution
Research Partner: Required. Formal collaborative effort between small business (minimum 40%) and research institution (minimum 30%)
Standard deadlines for the HHS SBIR/STTR Omnibus: January 5, April 5, September 5
For other FAQs about PI eligibility, please see our FAQs.
Submit Your SBIR/STTR Grant Application to NIH Electronically
Submit Your SBIR/STTR Grant Application to NIH Electronically
Submit via ASSIST or Downloadable Forms
Most small business applicants will submit their application using ASSIST or the downloadable forms method. Error-free applications must be accepted by Grants.gov with a time stamp on or before 5 p.m. local time of the submitting organization on the due date. NIH’s late policy does not allow corrections after the due date.
Track in eRA Commons
Once the application is submitted, the signing official (SO) or PI must check for errors or warnings in eRA Commons. Errors do STOP application processing and must be corrected. Warnings do not stop application processing and are corrected at the discretion of the applicant. Using ASSIST will help the applicant catch errors before submitting.
View in eRA Commons
Once an error-free application is received by NIH from Grants.gov, the eRA system will assemble the grant application image. Applicants have two business days to view the error free assembled application image before the application automatically moves forward for further processing.
The SO can reject application within viewing window and submit a Changed/Corrected application prior to the due date.
NIH Center for Scientific Review Evaluates Your Grant
NIH Center for Scientific Review Evaluates Your Grant on Scientific and Commercialization Potential
NIH uses a rigorous dual peer review system to ensure only the most meritorious scientific proposals are funded. For SBIR/STTR applications, a technology’s commercialization potential is also evaluated during the review process.
Funding Decisions and Awards are Made
Funding Decisions and Awards are Made
Once the applicant has gone through peer review, the Advisory Council/Board of the potential awarding Institute or Center (IC) performs the second level of review and gives advice to the IC staff and IC director. The IC director makes the final funding decisions based on staff and Advisory Council/Board advice.
Applicants must ensure that all of the Just-In-Time reporting requirements have been met, which includes the IRB approval, Federal-wide Assurance (FAW) and Human Subjects Education Training. View the NIH SBIR/STTR Just-in-Time (JIT) Procedures Module for information on how to submit all required documentation.
If the application is funded, the small business will receive a Notice of Award. If the application is not funded, the IC program officer can discuss how the application can be revised so it may be funded in the future.
Awardee Conducts Research
Awardee Conducts Research
The awardee will need a great deal of information to be a successful steward of federal funds. The NIH Welcome Wagon Letter provides information and resources for new grantee organizations on how to manage the award.
View the NIH Grants Policy Statement for comprehensive information about the post-award processes and requirements. For specific questions, consult the appropriate NIH program officer or grants management specialist.
Feasability Study for 6 Months to 1 year - $150K SBIR, $150K STTR
Niche
For Active Phase I Awardees
NIH’s SBIR/STTR Niche Assessment Program helps active Phase I awardees assess potential applications for their technology; the needs and concerns of the end-users; competing technologies and products; barriers to market entry; potential commercialization partners; and the price customers are likely to pay.
Niche Details
Phase I
The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R&D efforts prior to further federal support in Phase II. SBIR/STTR Phase I awards normally do not exceed $150,000 total costs for 6 months (SBIR) or 1 year (STTR).
Direct Phase II SBIR
SBIR Direct Phase II congressional authority has expired. Bypass Phase I if feasibility studies are completed. View NOT-OD-16-052 for revised eligibility criteria.
Full R&D for 2 Years - $1M SBIR, $1M STTR
CAP
For Phase II or IIB Awardees
The Commercialization Accelerator Program (CAP) is designed to help promising early-stage life science companies develop their commercial businesses and transition their SBIR/STTR - developed technologies into the marketplace. CAP trains Phase II awardees on how to develop tailored market entry strategies, build strategic partnerships, develop FDA regulatory and reimbursement paths, create financing strategies and understand intellectual property matters.
CAP Details
Phase II
The objective of Phase II is to continue the 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. SBIR/STTR Phase II awards normally do not exceed $1,000,000 total costs for 2 years.
$1M Per Year for Up to 3 Years - Must Have Initial Phase II to Apply
Phase IIB
Some NIH ICs offer Phase IIB awards for projects that require extraordinary time and effort in the R&D phase. These awards normally do not exceed $1,000,000 per year for up to 3 years. Talk to your IC program officer if your small business is interested in a Phase IIB award.
Commercialization Readiness Program (CRP)
The congressional CRP authority has expired. The Commercialization Readiness Program (CRP) is a pilot authority that may provide up to $3 million in additional funding for Phase II SBIR/STTR projects. The CRP may fund work that is not typically supported through SBIR/STTR Phase II or Phase IIB awards, including:
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Preparation of documents for a Food and Drug Administration (FDA) submission
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Development of an intellectual property strategy
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Investigational New Drug (IND)-enabling studies
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Clinical studies
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Manufacturing costs
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Regulatory assistance
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Subcontracted work to other institutions, including contract research organizations (CRO)
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A combination of services
Commercialization - Non-SBIR/STTR Funds
Phase III
The objective of Phase III is for the small business to pursue commercialization objectives resulting from the Phase I/II/IIB R&D activities. The NIH SBIR program does not fund Phase III.
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