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