Course 2, Tutorial 5: Department of Health and Human Services

The Department of Health and Human Services is the funding agency of choice for many life sciences startups.

Who Awards SBIR/STTR in HHS?

Within the Department of Health and Human Services, the major SBIR granting institution is the National Institutes of Health (NIH). The NIH has a broad mission that involves applying knowledge for the benefit of health enhancement, longevity, and reduction of disability and illness. Within the NIH are 27 Institutes and Centers (ICs), 23 of which provide SBIR or STTR awards. Of the many NIH Institutes and Centers, the National Cancer Institute (NCI) has the largest budget, followed by the National Institute of Allergies and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI).

The Funding Opportunity

The NIH’s SBIR and STTR programs usually release their funding opportunity announcements (FOA) as omnibus solicitations, through which applicants can submit a project to be considered by any of the 23 NIH ICs, the Center for Disease Control (CDC), and the Food and Drug Administration (FDA). Uniquely within HHS, the omnibus solicitation for a given year has three due dates, usually in January, April, and September. The NIH always recommends that you contact the IC Program Manager before submitting an SBIR application, as the Program Manager’s job is to know the solicitation and how it is being interpreted by the IC.

The hard cap for Phase I SBIR and STTR awards is $225,000 and Phase II awards are capped at $1.5 million. For a proposal that justifies the need for additional funding and addresses a topic on SBA’s approved list for additional funding, these caps can be exceeded via a waiver.

Applicants generally have a 12-14% chance of winning a Phase I SBIR or STTR award from the NIH, based on 2016 numbers. The review process involves applications being initially reviewed, assigned to particular ICs and then reviewed again.

Benefits to Awardees

HHS works with two technical assistance programs to help awardees. Foresight S&T offers the Niche Assessment Program to Phase I awardees to find competitive advantages and market entry strategies, as well as other potential uses of the technology. LARTA provides the Commercialization Accelerator Program to Phase II awardees to assist with strategic/business planning, looking at FDA requirements, manufacturing, patent/licensing issues, and valuing the technology.