Mission

HHS is one of the five federal departments that participates in both the SBIR and STTR programs. 

HHS is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The four goals of the HHS SBIR/STTR programs are: to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; to develop, maintain, and renew scientific human and physical resources that will assure the Nation’s capability to prevent disease; to expand the knowledge base in medical and associated sciences in order to enhance the Nation’s economic well-being and ensure a continued high return on the public investment in research; and to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

HHS is organized into a number of different Institutes and Centers that fund under a variety of health related areas. Operationally, HHS offers topics under the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). As NIH is the largest funder within HHS, the HHS SBIR/STTR programs are often referred to as the NIH SBIR/STTR programs, and the programmatic information sites are hosted by NIH.

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Requirements

To submit a proposal package, in addition to the general SBA requirements, a business must have registered in Grants.gov: https://www.grants.gov/.This is the portal that businesses will submit SBIR and STTR packages and retrieve required federal forms.

Mechanics of the Program

Under the HHS SBIR/STTR programs, the objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to providing further federal support in Phase II. Phase I funding and period of performance typically, does not exceed $150,000 and 6 months for an SBIR project, or 12 months for an STTR project. If the Phase I project is successful, companies can apply for Phase II funding. Phase II project funding typically does not exceed $1,000,000 for a period of 24 months to the R/R&D efforts initiated in Phase I on those projects that have validated their scientific and technical merit and commercial potential.

As Congressional Authority allows, HHS also carries a Direct-to-Phase II SBIR program. This program was instituted so that a federal funding agency may “issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development”. Essentially, if you are further along the development pipeline that a Phase I intends, you might be eligible to move directly to a Phase II project, and skip the initial “gate”. Direct to Phase II opportunities are listed separately from any solicitation, so pay attention to what programs allow for this mechanism. Also, this program is renewed on a periodic basis though, so please be aware of the status of the Congressional Authority before researching this option.

Additional Funding

HHS may allow awardees to seek a Phase IIB continuation to provide follow-on funding to small businesses for projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of projects such as drugs, devices, vaccines, therapeutics, and medical implants. Phase IIB awards are limited to $1M per year for up to 3 years and are only available to certain Institutes within HHS, so you will want to check program availability with your grant officer. 

HHS also offers several commercialization programs as congressional authority allows. All of these programs have a congressional expiration, so you will want to check on individual program availability when you are ready to move to transition to commercial efforts for your innovation.

The Niche Assessment Program (NAP) is available for Phase I awardees and is designed to help small businesses “jump start” their commercialization efforts. NAP provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application and be exposed to potential partners. Though there is no funding tied to this program, participation in NAP provides awardees with market analysis and market strategy on how to approach end-users and outside partners, and can be extremely valuable as awardees ready their commercialization plan for a Phase II submission.

The Commercialization Accelerator Program (CAP) is available for either current Phase I or Phase II awardees, or businesses who had an active award within the past 5 fiscal years. CAP is a 9 month program that offers deep domain expertise and access to industry connections. Accepted applicants will be put into one of three tracks based on background and experience and are paired with a Principal Advisor (PA) who brings deep industry, entrepreneurial experience, and technology and business expertise to the project. Though CAP provides no direct funding to the businesses, participation is free. 

The Commercialization Readiness Pilot (CRP) Program provides either technical assistance or late stage development assistance to current or prior Phase II or Phase IIB awardees. The purpose of the CRP program is to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by providing additional support for technical assistance not typically supported. CRP offers either up to $300,000 for up to 2 years, or up to $3,360,358 for up to 3 years dependent on scope and level of assistance being sought.

Additionally awardees are always encouraged to seek other funding mechanisms to transition their work into a Phase III.

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Resources

For a full listing of agency resources and NM FAST resources, relevant to an SBIR or STTR submission to NIH, please visit this link: