Annually, 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 latest versions are out now:
- PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42], Clinical Trial Not Allowed)
- PHS 2024-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44], Clinical Trial Not Allowed)
U.S. small business concerns may apply if they meet the Small Business Eligibility Criteria. These NOFOs fund investigator-initiated research, meaning you as the applicant can choose any research topic that reflects your interests and expertise.
NIAID does not participate in the “Clinical Trial Required” versions of these two NOFOs; instead, we invite SBIR/STTR clinical trial applications through NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required). Find further guidance in Investigator-Initiated Clinical Trial Resources.
Note also that the SBIR/STTR parent NOFOs are distinct from the recently published Solicitation of NIH and CDC for SBIR Contract Proposals. We will cover that contract solicitation in the next issue of this newsletter.
Scientific Priorities
To accompany the annual SBIR/STTR parent NOFOs, NIH assembles a list of scientific priorities for small business awards that match the research interests of its institutes and centers. The full list is more than 100 pages in length.
NIAID’s section provides an overview and key areas of interest from pages 18 to 32. Take a look at SBIR/STTR Grant Applications: NIH, CDC, and FDA Program Descriptions and Research Topics.
Here are a few examples of research areas we would like to fund:
The Targeted Interventions Branch within our Division of AIDS is interested in the discovery and development of small molecule inhibitors with novel or underexplored mechanisms of action using standard and high-throughput technologies; cell-based and gene therapies; RNA-based therapeutics; next-generation biologics; novel targeting and delivery vehicles for agents active against HIV; therapeutic vaccines and monoclonal antibodies; protein chemistry-based anti-HIV approaches; assays to quantitate latent virus; animal models to facilitate evaluation of agents to treat or cure HIV infection.
The Autoimmunity and Mucosal Immunology Branch within our Division of Allergy, Immunology, and Transplantation will support preclinical and clinical research that seek to develop and improve therapies for the treatment of autoimmune diseases and primary immune deficiencies/inborn errors of immunity (not HIV). Such projects could examine the basic research of autoimmune disease mechanisms and biomarkers, immunotherapy of disease processes, disorders that are mediated by lymphocyte products and the discovery and/or development of reagents for analysis of mucosal immunity.
The Virology Branch within our Division of Microbiology and Infectious Diseases is interested in research on acute viral infections caused by arthropod-borne and rodent-borne viruses; persistent viral infections caused by viruses; acute and chronic infections with hepatitis viruses; and transmissible spongiform encephalopathies. SBIR/STTR applicants could develop vaccines and vaccine platforms; develop techniques to improve vaccine stability; identify antiviral targets and agents; design and synthesize novel antiviral agents; develop therapeutic, prophylactic, and postexposure prophylactic interventions; develop and validate point-of-care assays for disease diagnosis and to measure response to therapy; develop new preclinical animal model systems that predict clinical efficacy of vaccines, therapeutics, and diagnostics.
NIAID’s three program divisions span more than 20 branches for which you can find many more topics in addition to those listed above.
You may also identify an NIAID contact who matches your scientific area of interest through our High-Priority Areas of Interest for the NIAID Small Business Program index page.
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 $306,872 for Phase I awards and $2,045,816 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 HHS Approved SBIR/STTR Topics for Awards over Statutory Budget Limitations. 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.
Keep in mind that the figures listed above are limits, not standardized amounts provided for each award; in your application, you need to justify your specific budget request based on the actual needs of your proposed 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, 2024. Subsequent deadlines follow NIH’s Standard Due Dates. There are not separate due dates for AIDS and AIDS-related applications.
If this is your first time applying for NIH funding, keep in mind that it can be a time-intensive process—potentially 6 weeks or more to complete the registration process. Find out how to work through the Required Company Registrations to get started.
Find further 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 sign up to receive related information at Subscribe for NIAID Email Updates—select the "Small Business Awards" category under NIAID Funding Opportunities in the Grants & Contracts section.
To find NIAID small business funding opportunities, choose the "Small Business" category under Grant Type in the left navigation on NIAID’s Funding Opportunities page.
Recent Policy Updates
As a quick reminder, small business concerns are 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.
A recording of the America’s Seed Fund: NIH’s Small Business Program Webinar, held on July 31, 2024, should become available shortly; once it posts, watch to learn about open funding opportunities, resources for how to apply, and relevant policy updates.