Grant Details

General Overview

Funding Information

Funding Organization: National Institutes of Health (NIH)

Total Funding Amount: Up to $2,045,816 for Phase II awards

Duration: Up to 3 years

Objective: To assist SBCs in advancing products/technologies requiring Federal regulatory approval or bringing complex research tools to market.

Context and History

This is a reissue of PAR-21-265, updated to align with agency priorities.

The program aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to commercialization.

Organizational Aspects

Eligible Organization Types

Only U.S. small business concerns (SBCs) are eligible to apply.

SBCs must be organized for profit and primarily operate within the U.S.

Size and Capacity Requirements

SBCs must have not more than 500 employees.

Scope and Focus

Primary Focus Areas

Support for exploratory clinical trials or studies contributing to future trials.

Focus on medical biotechnology products, particularly for rare diseases and small patient populations.

Expected Outcomes

Applications must aim to generate data that inform further clinical development.

Plans for future development must be outlined in case of promising results.

Technical Details

Technical Expertise Requirements

Applications must demonstrate readiness for FDA approval if applicable.

Studies should be designed to minimize bias and ensure validity.

Financial Structure

Budget and Funding Requirements

Total funding support normally may not exceed $2,045,816 for Phase II awards.

Independent third-party funding equal to or greater than one-third of the NINDS funds requested is expected.

Timeline and Implementation

Key Dates

Earliest Submission Date: August 05, 2024

Application Due Dates: Various dates from September 05, 2024 to April 05, 2027.

Compliance and Requirements

Regulatory Compliance

IRB approval is required prior to funding.

Documentation of necessary regulatory approvals must be provided.

Application Process

Required Documentation

Applications must follow SBIR/STTR instructions in the How to Apply – Application Guide.

Documentation of third-party investor commitments is required.

Grant Details

neurology clinical trials biotechnology small business medical devices rare diseases research funding healthcare innovation SBIR STTR
NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB)
PAR-24-221
SBIR/STTR
SME ENTERPRISE
US
HEALTHCARE TECHNOLOGY
DEVELOPMENT EARLY_MARKET
0-10 11-50 51-250 251-500
SDG3
FUNDING RESEARCH_DEVELOPMENT
None
2045.82
1000.00
2045.82
USD
100.00
April 6, 2027, 5 p.m.
Not specified