NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
ID: 352061Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/352061

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-099.html
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44), aimed at supporting small business concerns (SBCs) in conducting investigator-initiated clinical trials that align with the NIAID research mission. This funding opportunity encourages high-impact, hypothesis-driven studies, particularly those involving high-risk clinical trials with unique features such as non-routine interventions or the use of unlicensed products. Eligible U.S.-based SBCs can apply for a maximum award of $1 million per year for up to three years, with applications due by January 14, 2027. Interested applicants are encouraged to consult with NIAID staff prior to submission and can find more information at grants.nih.gov, or contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-099-Full-Announcement.html
    PAR-24-099.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), invites applications for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44). This funding opportunity aims to support small business concerns (SBCs) in conducting investigator-initiated clinical trials aligned with the NIAID research mission. Focused on high-impact, hypothesis-driven studies, it encourages high-risk clinical trials with unique features, such as non-routine interventions. Key dates include an open submission date starting April 12, 2024, with a final application due date of January 14, 2027. Eligible organizations are U.S.-based SBCs that meet specific ownership criteria and have fewer than 500 employees. The maximum award for Phase II is $1 million per year for three years, contingent upon NIH appropriations and application quality. The proposal process requires detailed planning of the clinical trial, with milestones and comprehensive regulatory compliance included. Submission is exclusively electronic via Grants.gov, and prior consultation with NIAID staff is encouraged to ensure alignment with agency goals. This funding initiative seeks to advance clinical research capabilities, particularly concerning infectious diseases, immunology, and related health challenges.
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