Each year, NIH solicits research proposals from small businesses through A Solicitation of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals. The latest version was published on August 2, 2024. The solicitation serves as a vehicle for offerors to propose research projects on a multitude of scientific topics from across NIH.
Proposals are due by October 18, 2024, at 5 p.m. Eastern Time.
NIH’s Small Business Education and Entrepreneurial Development (SEED) program will host an HHS SBIR Contract RFP Pre-proposal Conference Webinar (PHS-2025-1) to discuss the mechanics of the contract opportunity on September 23, 2024, from 2 to 4 p.m. Eastern Time. The presentation materials will be posted on that same event page following the session.
Note: This SBIR contract solicitation is distinct from the 2024 SBIR and STTR Omnibus/Parent Grant Solicitations for the NIH, CDC, and FDA released in July, which are notices of funding opportunities for grant awards (despite the word “solicitation” appearing in their titles). Learn about those grant opportunities in our August 7, 2024 article “Small Business Research: Priority Funding Topics for 2025.”
To differentiate among the proposal types:
- Phase I—research to determine the scientific or technical feasibility and commercial merit of the proposed research or research and development (R&D) efforts.
- Phase II—continuance of Phase I research efforts, dependent on successful Phase I results as well as scientific and technical merit and commercial potential of further work.
- Fast Track—simultaneous submission of Phase I and Phase II proposals, to facilitate a streamlined transition from Phase I to Phase II if merited by research outcomes.
- Direct-to-Phase II—allows a small business concern to commence with Phase II research if Phase I stage-type research funded through other, non-SBIR/STTR sources is already complete.
The table below summarizes NIAID’s research topics of interest for contract proposals. Refer to the attachment posted within the solicitation linked above for full details, including the number of anticipated awards and descriptions of required activities and deliverables.
| Topic Number and Title | Project Goal | Proposal Types | Budget (Total Costs) |
| 137. New Drug Classes with Novel Mechanisms of Action for HIV, Hepatitis B, and Tuberculosis | To develop new drug classes for HIV, HBV, or Mtb therapy with a different mode of action than FDA-approved drugs currently in use. HBV and Mtb drugs must be compatible with current antiretroviral regimens. | Phase I, Fast Track | Phase I: $300,000 each year for up to 2 years Phase II: $2 million for up to 3 years |
| 138. Devices and Materials-Based Platforms for the Delivery of Broadly Neutralizing Antibodies (bNAbs) | To develop devices and materials for administering HIV-1 bNAb(s) and bNAb derivatives that increase protection from infection. Devices or materials should demonstrate 1) sustained release and stability, 2) increased bioavailability, 3) increased protective durability, 4) increased concentration or dose, 5) reduced burden of administration, or 6) increased user acceptability of the bNAb(s) relative to standard intravenous or subcutaneous administration methods. | Phase I, Fast Track | Phase I: $300,000 each year for up to 2 years Phase II: $2 million for up to 3 years |
| 139. Rapid Diagnostic Assays for Self-Monitoring of Acute or Rebound HIV-1 Infection | To support early-stage diagnostic technologies as platforms for developing simple, low-cost, rapid diagnostic assays that enable individuals to directly detect HIV-1 during the earliest stages of initial infection or to monitor viral suppression in chronic treated infection, i.e., when antibody responses are not an accurate surrogate for viral load. | Phase I, Fast Track | Phase I: $300,000 each year for up to 2 years Phase II: $2 million for up to 3 years |
| 140. Adjuvant Discovery and Down-Selection for Vaccines Against Infectious and Immune-Mediated Diseases | To support screening for new adjuvant candidates for vaccines against infectious diseases, autoimmune and allergic diseases, or transplantation; candidate characterization; and early-stage optimization. Also, to support the down-selection of adjuvants for subsequent vaccine development in side-by-side comparisons.
| Phase I, Fast Track, Direct-to-Phase II | Phase I: $300,000 each year for up to 2 years Phase II: $1 million each year—with appropriate justification—for up to 3 years |
| 141. Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models | To develop and validate reliable monoclonal antibodies or other reagents that can identify and track primary immune cells (e.g., cell surface markers and receptors) or analyze immune function/responses (e.g., cytokines, chemokines, intracellular signaling) in non-mammalian models or underrepresented mammalian models. | Phase I, Fast Track, Direct-to-Phase II | Phase I: $300,000 each year for up to 2 years Phase II: $500,000 each year for up to 3 years |
| 142. Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases | To support preclinical development and optimization of a single lead adjuvant for use in vaccines to prevent or treat human disease caused by infectious pathogens or to treat immune-mediated diseases. The lead adjuvant may be a single entity or a combination adjuvant. Adjuvants may be chemical, biological, or genetic adjuvants. Adjuvants may be novel or may functionally replicate adjuvants used in licensed vaccines. | Phase I, Fast Track, Direct-to-Phase II | Phase I: $300,000 each year for up to 2 years Phase II: $1 million each year—with appropriate justification—for up to 3 years |
| 143. Development of Diagnostics for Mycoplasma genitalium (Mg) Infection | To develop a new, more rapid, nucleic acid-based test for the diagnosis and treatment of Mg infection. The test should detect Mg and determine macrolide and quinolone sensitivity in clinical specimens to aid resistance-guided therapy. | Phase I, Fast Track
| Phase I: $300,000 for up to 1 year Phase II: $1.5 million for up to 3 years |
| 144. Development of Medical Interventions for Treating Non-Tuberculosis Mycobacterial (NTM) Infections | To support preclinical investigational new drug (IND) enabling development of therapeutic products that target NTM infections. This includes 1) improved strategies and regimens for treatment of NTM infections, 2) newer chemical entities with demonstrated anti-NTM inhibitory activity in vitro and in vivo, 3) optimized analogs or formulations of established antimicrobials with anti-NTM activity, and 4) selected bacteriophages for treatment of NTM infection in combination with antibiotics. | Phase I, Fast Track, Direct-to-Phase II | Phase I: $300,000 for up to 1 year Phase II: $1.5 million for up to 3 years |
| 145. Diagnostics to Detect Host Immunity to Coccidioidomycosis (Valley fever) or Histoplasmosis | To develop an ex vivo, cytokine-release assay for the detection of coccidioidomycosis (Valley fever) or histoplasmosis. | Phase I, Fast Track, Direct-to-Phase II | Phase I: $300,000 for up to 1 year Phase II: $1.5 million for up to 3 years |
| 146. Discovery and Development of Oral Small-molecule Direct-acting Antivirals Targeting Viruses of Pandemic Potential | To support antiviral drug discovery, evaluation and development targeting one or more viral pathogens from the following RNA virus families with pandemic potential: coronaviruses, paramyxoviruses, bunyaviruses, togaviruses, filoviruses, picornaviruses, flaviviruses, and orthomyxoviruses. Proposals must have in hand a new chemical series with mode of action through inhibition of a viral target and confirmed antiviral activity in a cellular assay. | Phase I, Fast Track, Direct-to-Phase II | Phase I: $500,000 for up to 1 year Phase II: $2 million for up to 3 years |
| 147. Software or Web Services to Assess Quality and Reproducibility of Data and Information About Therapeutics and Vaccines | To develop digital tools that assess quality and reproducibility of research-based digital information for infectious disease therapeutics and vaccines. The proposed tools could be specific to a single digital platform and verify the quality and reproducibility of infectious disease data. Ultimately these approaches would enable the development of software or web services that quantify rigor and reproducibility of datasets underlying vaccines and treatments to infectious diseases. | Phase I, Fast Track | Phase I: $300,000 for up to 1 year Phase II: $1.5 million for up to 3 years |
Your contract proposal should address only one topic; if you wish to pursue multiple topics, submit a separate proposal for each topic. Submit your proposal(s) through the electronic Contract Proposal Submission. Direct any technical questions about the solicitation and NIAID’s topics to Jonathan Bryan in NIAID’s Office of Acquisitions at jonathan.bryan@nih.gov or 240-669-5180.
Find general information and advice on our Small Business Programs page and contact NIAID SBIR/STTR Program Coordinator Natalia Kruchinin, Ph.D., at kruchininn@mail.nih.gov for funding questions specific to small businesses.