Sponsor Deadline
Posted: 2/25/2025

NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

This Notice of Funding Opportunity (NOFO) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and may be proposed under this program.

Companion FOAs:

PAR-23-206 , R34 Planning Grant
PAR-24-100 , U01 Research Project (Cooperative Agreements)

Deadlines:

  • Letter of Intent Due Date(s): 30 days before the application due date
  • Application Due Date(s): May 13, 2024; Sep 13, 2024; Jan 13, 2025; May 13, 2025; Sep 15, 2025; Jan 13, 2026; May 13, 2026; Sep 14, 2026; Jan 13, 2027
  • AIDS Application Due Date(s): May 13, 2024; Sep 13, 2024; Jan 13, 2025; May 13, 2025; Sep 15, 2025; Jan 13, 2026; May 13, 2026; Sep 14, 2026; Jan 13, 2027

PAR-24-099 Expiration Date: January 14, 2027

Eligibility Requirements

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

Amount Description

NIAID will consider Phase I budget requests up to $300,000 total costs per year for up to 2 years (Fast-Track only); and Phase II or IIB budget requests up to $1,000,000 (total costs) per year for up to 3 years.

Funding Type
Eligibility
Posted
2/25/2025
Deadline
Sponsor: