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

Background
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. The 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.

Grant Details
The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) program provides a unique and focused opportunity for small business concerns (SBCs) interested in conducting clinical trials. This NOFO supports implementation of clinical trials from SBCs that propose clinical trials in research areas that are well-matched with the mission and goals of the NIAID. The proposed clinical trial should be hypothesis-driven and milestone-driven.

A clinical trial is defined by NIH as: 'A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.' The NOFO will support the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial such as training of study personnel; enrollment and recruitment of study subjects; investigational product costs; data collection, management and quality control; laboratory work and data analyses; study management and oversight; safety monitoring and oversight; establishment of committees to manage the complexity of the trial; preparation of the final study report; and other related post-trial activities.

Eligibility Requirements
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all specified criteria including being organized for profit with a place of business located in the United States, having not more than 500 employees, and meeting ownership requirements.

Period of Performance
Durations up to 2 years for Phase I (for Fast Track applications) and up to 3 years for Phase II may be requested.

Grant Value
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.

Place of Performance
All research and development activities associated with awards made under this NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) NOFO must be performed within the United States.