PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

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Description

This opportunity invites eligible US small businesses to apply for Small Business Innovation Research (SBIR) grants to support research and development projects that align with the missions of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). The program aims to stimulate technological innovation, meet federal R&D needs, and increase commercialization of innovations developed with federal funding. Projects must not include clinical trials under this solicitation.

SBIR grants are available for Phase I (feasibility and proof of concept), Phase II (full R&D), Fast-Track (combined Phase I/II), Direct to Phase II (NIH only), and Phase IIB (NIH only, for further development beyond Phase II). The program covers a broad range of health, biomedical, and related research topics. Applicants are encouraged to review the SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA for specific areas of interest.

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Due Dates

• September 5, 2024
• January 5, 2025
• April 5, 2025
• September 5, 2025

All applications are due by 5:00 PM local time of the applicant organization. These are standard NIH SBIR due dates; applicants are encouraged to apply early.

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Funding Amount

• Phase I: Up to $306,872 total costs for up to 6 months
• Phase II: Up to $2,045,816 total costs for up to 2 years
• Phase IIB (NIH only): Budget limits vary by institute/center and topic
• Budget waivers: Higher budgets may be allowed for specific topics (see approved topics for budget waivers)
• Project duration: 6 months (Phase I), 2 years (Phase II); propose a reasonable duration for your project

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Eligibility

• Applicant type: Only United States small business concerns (SBCs) are eligible.
  • Organized for profit, with a place of business in the US
  • No more than 500 employees (including affiliates)
  • Majority US ownership (see full eligibility criteria)
  • Certain venture capital, hedge fund, and private equity ownership structures are allowed for SBIR (not STTR)
• Foreign organizations: Not eligible. Foreign components may be allowed if justified.
• Principal Investigator: Must be primarily employed by the small business at the time of award and during the project.
• Multiple applications: Allowed if scientifically distinct.

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Application Process

1. Review the full funding announcement: PA-24-245
2. Register your organization: Complete registrations with SAM.gov, SBA Company Registry, eRA Commons, and Grants.gov.
3. Prepare your application: Follow the SBIR/STTR (B) Instructions in the NIH Application Guide.
4. Submit electronically: Use NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace.
5. Key requirements:
   • No clinical trials allowed under this solicitation (see companion NOFO PA-24-246 for clinical trial proposals)
   • Data Management and Sharing Plan required
   • Certification required for certain ownership structures
   • Adhere to all page limits and formatting requirements

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Additional Information

• Updated priorities: The solicitation was updated March 31, 2025; applicants should review the latest version before submission.
• Performance benchmarks: Companies with significant prior SBIR/STTR funding must meet transition and commercialization benchmarks (see full NOFO for details).
• Disclosure requirements: Applicants must disclose foreign affiliations and relationships as part of the Just-in-Time process.
• Companion opportunities: For STTR or clinical trial proposals, see PA-24-247 and PA-24-246.

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External Links

• Full Funding Announcement (PA-24-245)
• SBIR/STTR Program Descriptions and Research Topics
• NIH SBIR/STTR Funding Opportunities
• NIH Application Guide
• Budget Waiver Topics
• NIH Small Business Program Contacts
• Apply via Grants.gov

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Contact Information

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