Overview

The NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) supports United States small business concerns in bringing scientific innovations to the marketplace. Through the SBIR program, funding is available for feasibility studies as well as later research and development needed to develop a commercial product. This opportunity is offered by the National Institutes of Health (NIH), in partnership with the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).

The National Institutes of Health seeks fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The Centers for Disease Control and Prevention, as the world's premier public health institute, aims to protect the lives of all Americans, advancing health through science, technology, and innovation.

Funding and Benefits

The funding instrument for this opportunity is a grant. No award ceiling or award floor has been specified. Applications will compete for available funds with all other recommended applications following peer review and a second level of review by the appropriate national Advisory Council or Board.

Eligibility

Only United States small business concerns (SBCs), as defined by the Small Business Administration (SBA), are eligible to submit applications. Non-domestic (non-U.S.) entities, including foreign organizations, are not eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are also not eligible to apply. Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Application Process

Applicants must follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide, except where instructed otherwise in the Notice of Funding Opportunity (NOFO). Conformance to all requirements is required and strictly enforced. Applications that do not comply with these instructions may be delayed or not accepted for review.

Several submission options are available:

• NIH ASSIST system: Prepare, submit, and track applications online.
• Institutional system-to-system (S2S) solution: Prepare and submit applications to Grants.gov and eRA Commons.
• Grants.gov Workspace: Prepare and submit applications and use eRA Commons to track them.

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices. All applications will receive a written critique. Applications may undergo a committee process in which only those deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.

Deadline and Timeline

Key dates for this opportunity are as follows:

• Posted Date: May 28, 2026
• Open Date (Earliest Submission Date): August 5, 2026
• Application Due Dates: September 5, 2026; January 5, 2027; April 5, 2027
• Expiration Date: April 6, 2027

All applications are due by 5:00 PM local time of the applicant organization. Applicants are encouraged to apply early to allow adequate time to correct any errors found during submission. No late applications will be accepted.

Contact Information

National Institutes of Health
NIH SEED (Small business Education and Entrepreneurial Development)
Email: SEEDinfo@nih.gov
Phone: 301-402-2541