CREATE Bio Optimization Track for Biologics (SBIR-U44)

Funding Agency:
National Institutes of Health

This Funding Opportunity Announcement (FOA) supports SBIRs in the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging modalities) for disorders identified under the NINDS mission.  This track supports the further characterization and optimization of therapeutic agent(s) that showed promise as evidenced by relevant, rigorous, convincing in vivo studies.  Therefore, at the end of this funding period, successful projects will have delivered an optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track.

Companion FOA: PAR-17-456, U01 Research Project – Cooperative Agreement


  • Application Due Date(s): February 13, 2018; July 18, 2018; February 13, 2019; July 18, 2019; February 13, 2020; and July 20, 2020 , February 12, 2021
  • AIDS Application Due Date(s): May 7, 2018; September 7, 2018; May 7, 2019; September 7, 2019; May 7, 2020; and September 7, 2020, May 7 2021 

PAR-17-457 Expiration Date New Date May 8, 2021 per issuance of NOT-NS-20-054. (Original Expiration Date: September 8, 2020)

Agency Website

Eligibility Requirements

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.

Amount Description

Application budgets are not limited but must reflect the actual needs of the proposed project.  Budgets for these projects will normally remain under $700,000 total cost (direct costs, indirect costs, fee) per year in Phase I and $4,000,000 total cost for Phase II (no more than $1,500,000 in total costs per year in Phase II). Budget costs will likely fluctuate over the funding period based on the stage of the project. 

Funding Type





Engineering and Physical Sciences
Environmental & Life Sciences
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

February 12, 2021