The SBIR and STTR programs equip innovators with funding for projects intended for the Department of Health and Human Services.
The Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs are offered by the Department of Health and Human Services (HHS). These programs promote research in public health, medicine, and social services, and are made available through all of the subdivisions in the HHS, including the NIH, CDC, FDA, and ACF.
Government agencies are tasked with providing services that run the gamut from defense to commerce. These are absolutely crucial to the country’s prosperity, but services that protect health are vital to our everyday lives.
The Department of Health and Human Services (HHS) enhances the health and well-being of citizens through programs that promote research in social services, medicine, and public health. The HHS fosters sustained advances in the sciences through various internal agencies, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Administration for Children and Families (ACF), and much more.
The HHS and its divisions could not deliver sound health initiatives without input from the most innovative minds in the country, and the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs help foster these relationships.
In this blog, we’ll cover everything you need to know about the SBIR and STTR programs within HHS, as well as Team 80’s role in assisting with all of the accounting requirements.
Table of Contents
What is the purpose of the HHS SBIR and STTR programs?
What are the HHS eligibility requirements?
How do I apply for a Department of Health and Human Services SBIR and STTR award?
Who are the HHS program contacts?
What are the HHS SBIR and STTR 2023 topics?
How do I stay up-to-date on the latest HHS SBIR/STTR news?
Who has won an HHS SBIR Phase II award?
What is HHS SBIR?
The HHS SBIR program is a highly competitive three-phase award system that provides qualified small businesses with opportunities to propose innovative ideas that meet the federal government’s specific research and development (R&D) needs.
- Phase I is a feasibility study to evaluate the scientific and technical merit of an idea.
- Phase II expands on the results of Phase I and pursues the development of an idea. Businesses must have participated in a Phase I award to be considered for Phase II.
- Phase III focuses on the commercialization of Phase II results, and it requires the use of private sector or non-SBIR federal funding.
What is HHS SBIR?
The HHS STTR is similar to the SBIR program. It also consists of three phases—with Phase I exploring the scientific, technical, and commercial feasibility of an idea or technology; Phase II expanding on Phase I results; and Phase III moving the innovation from the laboratory into the marketplace.
The biggest difference between the two programs is that STTR requires the small business applicant to forge a partnership with nonprofit research institutions to complete the work and eventually commercialize the innovation.
What is the purpose of the HHS SBIR and STTR programs?
HHS SBIR and STTR programs operate at each of the 24 participating NIH Institutes and Centers (ICs), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and the Administration for Children and Families (ACF).
The purpose of the HHS SBIR and STTR programs is to support scientific excellence and technological innovation. Through the investment of federal research funds, these programs aim to protect the shared interests of our country’s citizens and build a strong national economy. The HHS programs achieve this by:
- Funding technological innovation
- Stimulating research and development needs
- Encouraging participation by women and socially/economically disadvantaged persons
- Increasing private sector commercializations
- Fostering cooperation between small businesses and research institutions
Of the 11 federal agencies that participate in SBIR/STTR programs, HHS is one of the most highly funded. In fiscal year 2019, federal agencies awarded a total of $3.3 billion in SBIR funding, with HHS and the Department of Defense (DoD) accounting for more than three-quarters of the total amount.
In 2019, agencies awarded $429.3 million in STTR funds, with HHS and DoD once again accounting for more than three-quarters of funding.
What are the HHS eligibility requirements?
First, you need an idea or technology that serves HHS’s research and technical needs. If you have that element in place, you are at a good starting point, but SBIR and STTR funding from HSS has strict eligibility requirements of which you should be aware.
SBIR
To be eligible for the HHS SBIR program, you must:
- Operate a for-profit business
- Employee fewer than 500 workers
- Be located in the United States
- Be at least 51 percent owned and operated by one or more U.S. citizens or permanent residents
STTR
STTR eligibility in HHS includes all of the same requirements of SBIR, but you also need to have a cooperative research and development relationship with a U.S. research institution. Your research institution must be an accredited college or university, a federal research and development center, or a nonprofit research organization.
HHS SBIR and STTR Phase I
There are multiple smaller agencies that constitute the U.S. DOT. Among those agencies, eight participate in SBIR projects. The eight operating administrations within the DOT include:
How much is the SBIR Phase I award?
HHS SBIR Phase I awards total up to $150,000.
How long is SBIR Phase I?
Awards cover a period of up to six months.
How much is the STTR Phase I award?
HHS STTR Phase I awards total up to $150,000.
How long is STTR Phase I?
Awards cover a period of up to one year.
HHS SBIR and STTR Phase II
In the HHS SBIR/STTR Phase II, funding is intended to further the research and development efforts initiated in Phase I. This R&D must exhibit the potential for commercial application and, in general, only Phase I awardees are eligible for Phase II funding. The success rate of HHS SBIR/STTR hovers around 60 percent for Phase II.
How much is the SBIR Phase II award?
HHS SBIR Phase II awards total up to $1 million.
How long is SBIR Phase II?
Awards cover a period of up to two years.
How much is the STTR Phase II award?
HHS STTR Phase II awards total up to $1 million.
How long is STTR Phase II?
Awards cover a period of up to two years.
The Application Process
- Find a funding opportunity. HHS publicizes funding opportunities through grant solicitations or funding opportunity announcements (FOAs). View SBIR and STTR funding opportunities here.
- Prepare your application. After you zero in on a topic, access application forms via the HHS online application preparation and submission system. HHS uses the same application system as the National Institutes of Health (NIH), which reports to HHS.
- Submit and follow application status. You’ll need to keep tabs on your application after you submit it to ensure no errors were made during the submission process. The service desk can help you.
Who are the HHS program contacts?
The HHS department includes contacts across various divisions, including the CDC, NIH, and FDA. You can find contacts by following this small business program managers site page.
As for a general HHS SBIR/STTR program contact, that would be:
Stephanie Fertig
HHS Small Business Program Lead
Email: SEEDinfo@nih.gov
Phone: (301) 435-2688
What are the HHS SBIR and STTR 2024 topics?
Available topics under the HHS SBIR/STTR banner are intended to buoy innovations that further the health and well-being of the American people. Some of the current 2024 topics include:
- RFA-DA-25-054: Harnessing Artificial Intelligence and Polypharmacology to Discover Pharmacotherapeutics for Substance Use Disorders (R43/R44 Clinical Trials Not Allowed)
- RFA-DA-25-053: Harnessing Artificial Intelligence and Polypharmacology to Discover Pharmacotherapeutics for Substance Use Disorders (R41/R42 Clinical Trials Not Allowed)
- RFA-ES-24-003: SBIR E-Learning for HAZMAT and Emergency Response (R43/R44 Clinical Trial Not Allowed)
And that’s just a small sampling of the scores of topics available from HHS SBIR/STTR. You can view all of the open topics on the department’s solicitation listing.
Who has won an HHS SBIR Phase II award?
HHS SBIR success stories demonstrate more than the willingness of a federal agency to dole out funding; they also display the entrepreneurial spirit of innovative small businesses. Here are a few noteworthy HHS SBIR success stories:
Small Business: Enchroma, Inc.
Total SBIR Investment: $1.15 million
Worldwide, there are more than 300 million people with color vision deficiency (CVD). To serve that population’s needs, Enchroma, Inc. developed a patented solution in the form of eyeglasses for people with CVD.
To create this technology, the Berkeley, CA-based company utilized the latest research on the genetics of color blindness and various photopigment-related anomalies and developed a model that demonstrates how people with red or green color blindness perceive colors.
Co-founder Andrew Schmeder said that early agency support through funding and external validation was crucial for the company’s success. “Having those pieces was really essential to talk to investors and convince them that it was a legitimate and well-thought-out idea.”
Small Business: Vecna Technologies
Total SBIR Investment: $3.1 million
Vecna Technologies implemented Veterans Point of Service (VPS), which provides veterans with convenient control of their own health information, while streamlining and standardizing basic patient-facing activities at Veterans Affairs (VA) medical centers and community-based clinics nationwide.
The technology was developed under the HHS SBIR program. Since then, Cambridge, MA-based Vecna has partnered with hospitals and healthcare centers across the country to implement the system. With revenue from the success of its patient solutions side of the business, Vecna funded its robotics division, which is finding its niche in the logistics and warehouse industries.
“We continue to innovate our platforms through the SBIR program—whether for automated check-in, infection disease surveillance, or even robotics—and bring those improvements to bear both within the DoD and the VA, and for our commercial communities,” said Deborah Theobald, CEO of Vecna Technologies.
Small Business: 23andMe
Total SBIR Investment: $4.1 million
When genotyping solutions were first introduced, customers were eager to learn more about who they are and where they came from. 23andMe took this one step further, becoming the only company to offer both an ancestry product and a genetic health assessment tool that provides customers with more than 75 online reports related to genetic health risks, carrier status, wellness and more.
23andMe test kits can be purchased from Target, CVS, Amazon, and the company’s website, with over 2 million genotyped customers worldwide. SBIR funding provided by HHS has helped the company to further advance genetic science. Today, the Mountain View, CA-based company’s research platform is the world’s largest consented, re-contactable database for genetic research.
“SBIR has accelerated research that benefits all of society—research that is central to our mission as a company,” said Rachel Reichblum and Catherine Afarian at 23andme.
Which divisions in the HHS have SBIR/STTR programs?
HHS has 12 operating divisions, including nine agencies in the U.S. Public Health Service and three human services agencies. These divisions administer a wide variety of health and human services and conduct life-saving research for the nation, protecting and serving all Americans.
The family of divisions operating under the HHS department consist of a wide and varied collection of crucial concentrations. Each subdivision has a specific mission, and each one offers an opportunity for SBIR/STTR program funding.
The different divisions include:
- Administration for Children and Families (ACF)
- Administration for Community Living (ACL)
- Administration for Strategic Preparedness and Response (ASPR)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Assistant Secretary for Administration (ASA)
- Assistant Secretary for Financial Resources (ASFR)
- Assistant Secretary for Health (ASH)
- Assistant Secretary for Legislation (ASL)
- Assistant Secretary for Planning and Evaluation (ASPE)
- Assistant Secretary for Public Affairs (ASPA)
- Center for Faith-Based and Neighborhood Partnerships (CFBNP)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare & Medicaid Services (CMS)
- Departmental Appeals Board (DAB)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office for Civil Rights (OCR)
- Office of Global Affairs (OGA)
- Office of Inspector General (OIG)
- Office of Intergovernmental and External Affairs (IEA)
- Office of Medicare Hearings and Appeals (OMHA)
- Office of National Security (ONS)
- Office of the General Counsel (OGC)
- Office of the National Coordinator for Health Information Technology (ONC)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
What are the HHS SBIR and STTR accounting requirements?
Securing funding from the HHS through the SBIR/STTR programs is no easy task. You need a dynamic combination of dedicated team members, work ethic, and perseverance to achieve all that’s necessary for application success.
However, skills, talent, and scientific vision will only get you so far. You must also meet the accounting benchmarks required by the federal government.
Some of the specific accounting requirements for SBIR include:
- Proper segregation of direct costs from indirect costs
- A robust timekeeping system
- Exclusion of unallowable costs
- Identification of cost by contract line items
- Accumulation of costs under general ledger control
Team 80 can handle all your HHS SBIR/STTR accounting concerns. Connect with us today to access the accounting tools, systems, and expertise needed to navigate this complicated procedure.
