Each year, NIH reissues the parent notices of funding opportunities (NOFOs) for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research project grants. The new versions are out now:
- PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44], Clinical Trial Not Allowed)
- PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42], Clinical Trial Not Allowed)
U.S. small business concerns may apply if they meet the Small Business Eligibility Criteria.
There are also “Clinical Trial Required” versions of those same two NOFOs; however, NIAID does not participate in them. We invite SBIR/STTR clinical trial applications through a different NOFO: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required). Find further guidance at Investigator-Initiated Clinical Trial Resources.
Search for a Hot Topic
To accompany the annual SBIR/STTR parent NOFOs, NIH assembles a list of scientific priorities for small business awards of interest to its institutes and centers. The resulting document is long; more than 100 pages!
NIAID’s contribution to the list begins on page 17 and runs through page 29. Check out PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.
Just to give a few examples:
The Pathogenesis & Basic Research Branch within our Division of AIDS is interested in technologies for at-home self-testing to directly detect HIV during the earliest stages of acute infection or viral rebound following long-term suppression of viremia; new targets or strategies to prevent HIV transmission, inhibit replication, control viremia in the absence of antiretroviral drugs, or eradicate reservoirs of HIV; and approaches for predicting post-treatment immunologic control of viral rebound.
The Allergy, Asthma and Airway Biology Branch within our Division of Allergy, Immunology, and Transplantation invites projects to develop biomarkers as diagnostic markers, markers of disease severity, or predictive markers for treatment effectiveness—particularly of immunologic interventions such as allergen immunotherapy for food and respiratory allergy; and to build new forms of allergen immunotherapy aimed at increased tolerogenic immune responses and decreased allergenicity.
The Virology Branch within our Division of Microbiology and Infectious Diseases seeks research on vaccines and vaccine platforms; techniques to improve vaccine stability; approaches to identify antiviral targets and agents; chemical design and synthesis of novel antiviral agents; therapeutic interventions; point-of-care assays for diagnosis and measuring therapy response; and preclinical animal model systems that predict clinical efficacy of vaccines, therapeutics, and diagnostics.
NIAID has more than 20 branches across its three program divisions—there are many more topics for you to consider beyond those listed above.
Refer also to our High-Priority Areas of Interest for the NIAID Small Business Program index page, which provides a path toward locating an NIAID contact who matches your scientific area of interest.
Request an Appropriate Budget
For the Omnibus NOFOs, your total SBIR or STTR funding support (direct costs, indirect costs, and fees) normally may not exceed $295,924 for Phase I awards and $1,972,828 for Phase II awards. However, NIH has a waiver from the Small Business Administration to exceed these total award amount hard caps if your application fits any NIH Topics for Budget Waivers. Find NIAID’s budget cap waiver topics starting on page 4.
For waiver topics, NIAID will allow:
- Phase I applications with budgets of up to $300,000 total costs each year for up to 2 years.
- Phase II or Phase IIB applications with budgets of up to $1 million total costs each year for up to 3 years.
In any case, you should propose a project budget and duration that is reasonable and appropriate for your research project.
Additionally, we strongly encourage Phase IIB SBIR applicants to secure substantial, independent third-party investor funds to help validate the commercial potential of their proposed product.
Omnibus Application Due Dates, Advice, and More
The next application deadline for the Omnibus NOFOs is September 5, 2023. Subsequent deadlines follow NIH’s Standard Due Dates. There are not separate due dates for AIDS and AIDS-related applications.
Follow the Omnibus application instructions carefully. You must apply electronically using NIH ASSIST (preferred), Grants.gov Workspace, or a System-to-System alternative. We encourage you to start the registration and application process promptly as described at NIH’s How To Apply.
Find guidance on NIAID’s Small Business Grant Application Process and get application advice and answers from the NIAID Small Business Program Team.
Learn more on the NIAID Small Business Programs website. You can also Subscribe for NIAID Email Updates and choose the Small Business category under Research Funding Opportunities.
Policy Changes Since Last Year
As a quick reminder, small business concerns are now responsible for following NIH’s Data Management and Sharing Policy, which you will need to account for in your grant application. Once funding appears likely, you will need to submit a Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form as part of the Just-in-Time process. Lastly, if your small business concern already has multiple awards, you should be mindful of the updated Minimum Performance Standards, which set benchmarks to ensure that successful applicants are also successful at progressing projects toward commercialization.
Attend the Navigating America’s Seed Fund at NIH Webinar on August 8, 2023, at 1 p.m. Eastern Time to learn about how to account for these changes when you next prepare an application.
Other Small Business Opportunities
In addition to the two Omnibus NOFOs we covered in this article, NIAID and NIH support other funding opportunities for small businesses, which you can find at the following links:
As with the Omnibus NOFOs, contact the NIAID Small Business Program Team for guidance and answers to your questions.