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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-21-057: Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

    Release Date: 11-19-2020Open Date: 01-22-2021 Due Dates: Multiple Close Date: 09-08-2023

    Background A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities are diverse, and can include ‘omics, imaging, behavioral, digital and physiologic endpoints, as well as composite biomarkers or biomarker signatures. Becaus ...

    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-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
  4. 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
  5. 75N91020R00043 : Detection, Diagnosis, Treatment, Prevention and Research of Pediatric Cancers and/or Rare Cancers

    Release Date: 11-20-2020Open Date: 11-20-2020Due Date: 07-23-2021Close Date: 07-23-2021

    Background About 11,050 children in the United States under the age of 15 will be diagnosed with cancer in 2020 (https://www.cancer.org/cancer/cancer-in-children/key-statistics.html). Cancer is the second leading cause of death in children ages 1 to 14. Similarly, as a group, rare cancers are the leading cause of cancer deaths in the United States (https://rarecancer.org/). For the purpose of this ...

    SBIRPhase IDepartment of Health and Human ServicesNational Institutes of Health
  6. PAR-21-030: Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)

    Release Date: 10-08-2020Open Date: 12-05-2020 Due Dates: Multiple Close Date: 09-06-2022

    Purpose This Funding Opportunity Announcement (FOA) encourages the translation of technology and therapeutic innovations from academic and other non-profit research sectors to the marketplace to advance the development of diagnostic and prevention tools or treatments for musculoskeletal, rheumatic or skin diseases. Small Business Concerns (SBCs) are encouraged to apply for this Small Business Inn ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  7. 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
  8. PAR-21-059: linical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

    Release Date: 11-19-2020Open Date: 01-22-2021 Due Dates: Multiple Close Date: 09-08-2023

    Background A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities are diverse, and can include ‘omics, imaging, behavioral, digital and physiologic endpoints, as well as composite biomarkers or biomarker signatures. Bioma ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  9. RFA-DA-22-001: Mobile Health Solutions to rectify digital inequality in communities affected by drug addiction (R43/R44 Clinical Trial Optional)

    Release Date: 04-27-2021Open Date: 07-13-2021Due Date: 08-13-2021Close Date: 08-14-2021

    Background Mobile health technologies, including wearable sensors, mobile apps, social media, and digital therapeutics, have been proposed and used as research tools, service tools, and medical device solutions for patients affected by SUD. The emergency conditions of the SARS-COV-2 pandemic have dramatically expedited adoption and increased the attention to mobile health and remote monitoring an ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  10. PAR-21-224: NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

    Release Date: 05-05-2021Open Date: 08-05-2021 Due Dates: Multiple Close Date: 04-06-2024

    Purpose: To facilitate the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies, NINDS has formed the Neurology Network of Excellence in Clinical Trials (NeuroNEXT, www.NeuroNEXT.org). NeuroNEXT has a Clinical Coordinating Center (C ...

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