CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U44 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission.  An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA). 

Companion FOAs:

PAR-17-456U01 Research Project – Cooperative Agreement ,

PAR-17-457U44 Small Business Innovation Research (SBIR) Cooperative, Agreement-Phase II and Fast Track,

PAR-18-542U01 Research Project – Cooperative Agreement 


  • Application Due Date(s): February 20, 2018, July 18, 2018, February 13, 2019, July 18, 2019, February 13, 2020, and July 20, 2020 , and 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-18-543 Expiration Date New Date May 8, 2021 per issuance of NOT-NS-20-056. (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.

Typical budgets for these projects will normally remain less than or equal to $1,000,000 per year in total cost for U44 Phase I and $1,500,000 per year in total cost for U44 Phase II.

Funding Type





Engineering and Physical Sciences
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

February 12, 2021