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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.


If no search results for your keyword(s) were found, you are encouraged to review Agency omnibus solicitations for additional funding opportunities. Omnibus solicitations are structured to be broad, extensive Programmatic issuances with research areas related to the petitioning Agency and are not limited to predetermined Topics/Subtopics. If upon reviewing you have additional questions, you may consider reaching out to the respective Agency for clarification regarding acceptable proposals (https://www.sbir.gov/agency-contacts).

  1. 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
  2. RFA-TR-21-010: Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

    Release Date: 01-13-2021Open Date: 03-13-2021 Due Dates: Multiple Close Date: 01-13-2022

    A. Overview While there are thousands of rare diseases, the number of underlying etiologies is much smaller. Moreover, many disease etiologies underly 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 molecu ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  3. RFA-CA-21-036: SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional)

    Release Date: 03-25-2021Open Date: 07-06-2021Due Date: 08-06-2021Close Date: 08-07-2021

    Purpose The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) and other Federal agencies help bring innovative solutions to public health challenges. A major objective of the Federal SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of medi ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  4. RFA-DA-22-019: Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development (R43/R44- Clinical Trial Not Allowed)

    Release Date: 04-08-2021Open Date: 07-10-2021Due Date: 08-10-2021Close Date: 08-11-2021

    Background. SUDs are a set of complex and chronic diseases with an interplay between genetic and environmental factors. In the constellation of SUDs, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) provides a framework that includes ten separate classes of substances and covers 11 different criteria for their diagnosis. Currently, there are a limited number of pha ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  5. RFA-HD-22-010: Technologies to Advance Precision Medicine for Reproductive Health and Infertility (R43, R44 Clinical Trial Optional)

    Release Date: 03-31-2021Open Date: 06-29-2021Due Date: 07-29-2021Close Date: 07-30-2021

    Purpose/Research Objectives The purpose of this FOA is to stimulate the small business community through the Small Business Innovation Research (SBIR) grant program to adapt discoveries in genomics, epigenomics and biomarker identification to the clinical diagnosis and treatment of couples with infertility, and diseases and disorders that affect fertility. This initiative would foster collaborati ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  6. RFA-HG-21-008: Transformative Nucleic Acid Sequencing Technology Innovation and Early Development (R43/R44 Clinical Trial not Allowed)

    Release Date: 03-30-2021Open Date: 05-26-2021 Due Dates: Multiple Close Date: 02-02-2023

    Purpose This Funding Opportunity Announcement (FOA) solicits R43/R44 grant applications to innovate and develop the early commercial stages of novel technologies that will enable greater than a one order of magnitude improvement in DNA sequencing, or methods for direct sequencing of the diversity of entire RNA molecules. Advances in genomics and more broadly in biomedical research have been great ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  7. RFA-HD-22-019: User-Based Design to Aid in Contraceptive Development by Small Business (R43 Clinical Trial Not Allowed)

    Release Date: 03-30-2021Open Date: 06-29-2021Due Date: 07-29-2021Close Date: 07-30-2021

    The purpose of this Funding Opportunity Announcement (FOA) is to invite SBIR applications to study/identify characteristics that inform acceptability, desirability, and excitement of potential end-users of novel contraceptive products currently in the development pipeline for both men and women. Background In the United States, a large proportion of births are either mistimed or unwanted. The maj ...

    SBIRPhase IDepartment of Health and Human ServicesNational Institutes of Health
  8. RFA-DA-22-021: Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development (R41/R42- Clinical Trial Not Allowed)

    Release Date: 04-08-2021Open Date: 07-10-2021Due Date: 08-10-2021Close Date: 08-11-2021

    Background SUDs are a set of complex and chronic diseases with an interplay between genetic and environmental factors. In the constellation of SUDs, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) provides a framework that includes ten separate classes of substances and covers 11 different criteria for their diagnosis. Currently, there are a limited number of phar ...

    STTRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  9. RFA-HD-22-018: Biomarker Research to Support Fertility Regulation Development by Small Business (R43 Clinical Trial Optional)

    Release Date: 04-15-2021Open Date: 06-29-2021Due Date: 07-29-2021Close Date: 07-30-2021

    Purpose The purpose of this Funding Opportunity Announcement (FOA) is to invite SBIR applications to support and facilitate the development of new and/or improved clinical biomarkers and companion biomarker diagnostics (e.g., point of care and/or direct-to-consumer tests, DTC) to support the clinical development of non-hormonal contraceptive product(s) for men and women. Background Nearly half ...

    SBIRPhase IDepartment of Health and Human ServicesNational Institutes of Health
  10. PAR-21-233: Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

    Release Date: 04-23-2021Open Date: 07-10-2021 Due Dates: Multiple Close Date: 04-06-2024

    A. Overview Recent advances in biology offer unprecedented opportunities to discover new treatments for nervous system disorders. Biotherapeutic development, however, has inherent complexities with regards to characterization, manufacturing, delivery, and administration. Many academic laboratories and small business enterprises don’t have the full scope of expertise and resources available; thi ...

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