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NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should visit the respective agency SBIR sites to read the official version of the solicitations and download the appropriate forms and rules.

  1. RFA-TR-24-001: Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

    Release Date: 12-01-2023Open Date: 12-04-2023 Due Dates: Multiple Close Date: 03-16-2024

    While there are thousands of rare diseases, the number of underlying etiologies is much smaller. Moreover, many disease etiologies underlie multiple traditional diseases. This is most readily seen for rare monogenic diseases, where the most common etiologies include premature termination codons, protein misfolding, and abnormal RNA splicing. Other examples of rare disease shared molecular etiologi ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  2. RFA-DA-25-052: Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional)

    Release Date: 10-25-2023Open Date: 02-14-2024Due Date: 03-14-2024Close Date: 03-15-2024

    Substance use disorder (SUD) clinical trials traditionally perform recruitment, enrollment, interventions, as well as information collection at the clinical trial sites. In-person visits at the sites are used for screening, assignment to interventions, treatment or other intervention, follow up, as well as collection of information from participants and entering it in a database. Some of the in-p ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  3. RFA-HL-23-008: NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)

    Release Date: 11-16-2021Open Date: 01-28-2022 Due Dates: Multiple Close Date: 02-29-2024

    Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease.? It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  4. RFA-HL-23-009: NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)

    Release Date: 11-16-2021Open Date: 01-28-2022 Due Dates: Multiple Close Date: 02-29-2024

    Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease. It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  5. 75N91024R00006: Research and development (R&D) that will contribute toward Advanced Research Projects Agency for Health (ARPA-H) mission needs and Small Business Innovation Research (SBIR) program objectives

    Release Date: 01-23-2024Open Date: 01-23-2024Due Date: 02-22-2024Close Date: 02-22-2024

    The Advanced Research Projects Agency for Health (ARPA-H) invites small business concerns (SBCs) to submit research proposals under this Small Business Innovation Research (SBIR) Contract Solicitation. Firms with the capability to conduct research and development (R&D) and to commercialize the results of that R&D, are encouraged to participate. This solicitation invites proposals in the followin ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  6. RFA-NS-21-022: Translational Neural Devices (U44 Clinical Trial Optional)

    Release Date: 04-28-2021Open Date: 06-01-2021 Due Dates: Multiple Close Date: 02-21-2024

    A. Purpose The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical saf ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  7. PAR-21-082: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

    Release Date: 01-14-2021Open Date: 04-14-2021 Due Dates: Multiple Close Date: 01-15-2024

    Purpose This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. A clinical trial is defined by NIH as: "A research study in which one or more human subjects are prospectivel ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  8. PAR-21-114: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)

    Release Date: 01-25-2021Open Date: 03-05-2021 Due Dates: Multiple Close Date: 01-06-2024

    Purpose NINDS is committed to advancing diagnostics and treatments for people burdened by neurological diseases, and the NINDS Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies and therapeutics for the diagnosis and treat ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  9. PAR-21-297: Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed)

    Release Date: 08-31-2021Open Date: 11-09-2021 Due Dates: Multiple Close Date: 12-10-2023

    The objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative long-acting systemic and non-systemic multipurpose prevention technologies (MPT). It supports development of MPTs that prevent HIV infection and pregnancy (hormonal and non-hormonal methods) in adolescent and young women. Applications for MPT development may involve pharmacokinetic (PK) ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  10. NIH/NCATS 024: Small Manufacturing Systems to Produce Research Grade Pharmaceutical Intermediates

    Release Date: 08-25-2023Open Date: 08-25-2023Due Date: 11-14-2023Close Date: 11-14-2023

    (Fast-Track and Direct to Phase 2 proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I offerors with their long-term strategic planning.) Number of anticipated awards: 2 to 3 Budget (total costs, per award): Phase I: $325,000 for 9 months; Phase II: $2,000,000 for 2 years It is strongly suggested that proposals adhere to the above budge ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
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