Funder: National Institutes of Health
Due Dates: September 13, 2024 | January 13, 2025 | May 13, 2025 | September 15, 2025 | January 13, 2026 | May 13, 2026 | September 14, 2026 | January 13, 2027 (see full list for AIDS and non-AIDS cycles)
Funding Amounts: Up to $1,000,000 total costs per year for up to 3 years (Phase II/IIB); Fast-Track Phase I up to $300,000/year for up to 2 years; budgets must be well justified and may exceed these caps for approved topics.
Summary: Supports U.S. small businesses to conduct investigator-initiated, milestone-driven clinical trials aligned with NIAID’s mission, with emphasis on high-risk studies and non-routine interventions.
Key Information: Prior consultation with NIAID at least 10 weeks before the deadline is strongly encouraged; all clinical trial planning must be complete at submission; only one clinical trial per application.
Description
This opportunity provides funding for U.S. small businesses to implement investigator-initiated clinical trials that align with the research mission of the National Institute of Allergy and Infectious Diseases (NIAID). The program is designed to support hypothesis-driven, milestone-driven clinical trials, with a particular focus on high-risk studies—defined by the use of non-routine interventions, unlicensed products, or licensed products for unapproved indications (not necessarily higher risk to human subjects). Mechanistic studies may also be included.
The program is intended for clinical trials that cannot be conducted through existing NIAID-supported networks or infrastructure. Only one clinical trial may be proposed per application, and all planning activities must be completed prior to submission (except for Fast-Track applications).
Due Dates
- Standard Deadlines:
- September 13, 2024
- January 13, 2025
- May 13, 2025
- September 15, 2025
- January 13, 2026
- May 13, 2026
- September 14, 2026
- January 13, 2027
- AIDS-Related Applications:
- Same dates as above (see full schedule)
- Letter of Intent: 30 days prior to the application due date (optional but recommended)
- Expiration Date: January 14, 2027
Funding Amount
- Phase II/Phase IIB: Up to $1,000,000 total costs per year for up to 3 years.
- Fast-Track Phase I: Up to $300,000 total costs per year for up to 2 years.
- Budget Justification: Budgets must be reasonable and appropriate for the proposed research. NIH may approve budgets above these caps for specific topics (see current list of approved topics).
- Technical and Business Assistance (TABA): Additional funds may be requested (see TABA details).
Eligibility
- Applicant Type: U.S. small business concerns (SBCs) as defined by the Small Business Administration (SBA).
- Location: Must be organized for profit and have a place of business in the United States.
- Ownership: Must be majority U.S.-owned and controlled; see SBIR eligibility criteria.
- Employee Limit: No more than 500 employees, including affiliates.
- Foreign Organizations: Not eligible; all R&D must be performed in the U.S. (rare exceptions require strong justification).
- PI Requirements: For SBIR, the PI’s primary employment must be with the small business at the time of award and during the project.
- Application Limits: Multiple applications allowed if scientifically distinct; only one clinical trial per application.
Application Process
- Prior Consultation: Strongly encouraged to contact NIAID staff at least 10 weeks before the deadline to discuss program fit, risk level, and documentation requirements.
- Submission: Applications must be submitted electronically via Grants.gov or NIH ASSIST.
- Required Registrations:
- Application Components:
- SF424 (R&R) forms
- SBIR/STTR Information Form
- PHS 398 Research Plan (including complete clinical protocol as appendix)
- Data Management and Sharing Plan
- Letters of Support
- Budget Justification
- Human Subjects and Clinical Trials Information (if applicable)
- Page Limits: Follow NIH Table of Page Limits.
- Review Criteria: Scientific merit, innovation, approach, environment, and commercialization potential. See full review criteria.
Additional Information
- Scope: Supports only implementation of clinical trials (not planning activities, except for Fast-Track).
- Milestones: Applications must include clear, measurable milestones; these will be incorporated into the terms of award.
- Non-Responsive Applications: Will not review applications proposing more than one clinical trial, platform trials, or those using existing NIAID network resources without prior approval.
- Foreign Disclosure: Applicants must comply with new foreign disclosure requirements.
- Data Rights: SBIR/STTR recipients may retain data rights for up to 20 years after award.
- ClinicalTrials.gov Registration: Required for applicable clinical trials.
- Award Mechanism: Cooperative Agreement (U44) with substantial NIH programmatic involvement.
External Links
Contact Information