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Transforming the understanding
and treatment of mental illnesses.

Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Programs

SBIR/STTR Program 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.

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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.

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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.

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Complete Required Registrations

Required Registrations:

You must complete multiple registrations prior to preparing an application and applying for funding. All registrations must be completed prior to the application being submitted.

It can take 6 weeks or more to complete the registration process.

  • SAM (System for Award Management) – required to do business with the U.S. government
    • SAM will issue a 12-character unique entity identifier (UEI) used to complete your full SAM registration and which serves as the official organization identifier in other federal systems
  • eRA Commons – required to do business with NIH and some HHS agencies
  • Grants.gov – required to submit grant applications through the federal-wide grant portal
  • SBA (Small Business Administration) – required to participate in SBIR and STTR federal funding programs
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SBIR Omnibus
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STTR Omnibus
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Targeted SBIR/STTR FOAs

Prepare Your Application

How to Apply - Application Guide, use the “SBIR/STTR Instructions”

Follow the funding opportunity instructions

  • “Section IV. Application and Submission Information” contains opportunity-specific guidance not contained in the application guide
  • Related Notices, which are listed in Part 1. Overview information

Find guidance, resources for first-time applicants, and all the necessary forms in one convenient location.

Standard deadlines for the HHS SBIR/STTR Omnibus: January 5, April 5, September 5

For additional information please see our FAQs

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Submit Your SBIR/STTR Grant Application to NIH Electronically

Submit Your SBIR/STTR Grant Application to NIH Electronically

Submit via ASSIST
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.

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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.

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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.

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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.

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Phase
I

Proof of Concept/ Feasibility Study for 6 months to 2 years

TABA Needs Assessment

For Phase I Awardees
This Technical and Business Assistance (TABA) program is intended to help NIH SBIR/STTR Phase I awardees and Phase I Fast-Track awardees identify and address their most pressing product development needs. The program provides a third-party assessment of 10 key business development considerations and identifies the company’s highest priority next steps. Full details and eligibility: NOT-OD-21-023

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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. See Budget and Timelines for Funding for additional information.

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FAST
TRACK

Fast Track

One application for Phase I and Phase II that is submitted and reviewed together.

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Direct
Phase II

Direct Phase II SBIR

The Congressional authority for SBIR Direct Phase II is reinstated until FY2022. Bypass Phase I if feasibility studies are completed. 

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Phase
II

Full R&D for 1 to 3 Years

TABA Consulting Services

For Phase II or IIB Awardees
Technical and Business Assistance (TABA) program to help NIH SBIR/STTR Phase II/IIB awardees in one of the following areas:

Intellectual Property
Market Analysis
Regulatory Affairs
Reimbursement Planning

For more information see the TABA Consulting Services webpage.

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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. See Budget and Timelines for Funding for additional information.

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Phase
IIB

$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.

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CRP

Commercialization Readiness Program (CRP)

SBIR or STTR-supported projects may benefit from funding and support above and beyond the Phase II or Phase IIB awards. The CRP Program provides additional technical assistance and late-stage research and development support not typically covered within small business awards to help products get to market.

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Phase
III

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.

Helpful Links:
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