NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

HHS-NIH11 PA-27-101
Posted: May 28, 2026 12:00:00 AM EDT
Closes: 04/05/2029

Description

The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R&D).

Synopsis

The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R&D).

Eligibility

Eligible Applicants:
Small businesses
Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project. This NOFO supports Renewal/Resubmission "Type 2" Applications from recipients with NIH Phase II SBIR/STTR awards that are submitted within the first six due dates following the expiration of their budget period. Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Funding Activity Categories

Health

CFDA Numbers

  • 93.233 - National Center on Sleep Disorders Research
  • 93.242 - Mental Health Research Grants
  • 93.273 - Alcohol Research Programs
  • 93.307 - Minority Health and Health Disparities Research
  • 93.313 - NIH Office of Research on Women's Health
  • 93.350 - National Center for Advancing Translational Sciences
  • 93.351 - Research Infrastructure Programs
  • 93.393 - Cancer Cause and Prevention Research
  • 93.394 - Cancer Detection and Diagnosis Research
  • 93.395 - Cancer Treatment Research
  • 93.837 - Cardiovascular Diseases Research
  • 93.838 - Lung Diseases Research
  • 93.839 - Blood Diseases and Resources Research
  • 93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
  • 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research
  • 93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders
  • 93.855 - Allergy and Infectious Diseases Research
  • 93.859 - Biomedical Research and Research Training
  • 93.865 - Child Health and Human Development Extramural Research
  • 93.866 - Aging Research
  • 93.867 - Vision Research

Contact Information

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

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 2
Last Updated: Jun 01, 2026 12:56:46 PM EDT

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