NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for small businesses innovating in health research and development. Applicants must be for-profit companies with 500 or fewer employees. The business must conduct substantial research, development, or commercialization work. Both Phase I (R43) and Phase II (R44) awards are available. Projects may include clinical trials, though they're optional components.
Geographic scope covers the entire United States. Eligible institutions include domestic small businesses and spin-offs from universities or government labs. Foreign entities and their subsidiaries are generally ineligible. Organizations must have appropriate intellectual property rights to the technology being developed.
Not the right fit? Find grants for your organization in 5 questions →
Key dates
- May 28, 2026 Applications open
- Mar 1, 2027 Award announced
- Apr 1, 2027 Project start
- Apr 5, 2027 Application deadline in 262 days
Program description
The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): NEI, NHLBI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NINDS, NINR, NIMHD, NLM, NCCIH, NCATS, ORIP, NCI and ORWH, along with the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA), intends to publish a Notice of Funding Opportunity (NOFO) to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), and Fast-Track (NIH only) grant applications. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R43/R44 activity code. United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, and FDA awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise will be encouraged, and these investigators should also begin considering applying for this application.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative (Research Plan)
- Budget and Budget Justification
- Biographical Sketches (key personnel)
- Phase I or Phase II Justification (for Phase II applications)
- Facilities and Other Resources
- Letters of Support (from commercialization partners or customers)
Program contact
- 👤 NIH SEED (Small business Education and Entrepreneurial Development)
- 📧 SEEDinfo@nih.gov
- 📞 301-827-8595
Funding track record
Recent awards under CFDA 93.143 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$51,240,024
-
$49,457,978
-
$45,744,612
-
$44,099,726
-
$43,756,790
-
$41,458,690
-
$40,627,455
-
$38,585,087
-
$34,167,376
-
$33,366,179
Top States by Funding
- CA 12 awards $132.7M
- NY 8 awards $79.6M
- NC 7 awards $77.2M
- MA 6 awards $68.7M
- MI 5 awards $53.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.143). How funding has trended year over year.
| 2024 | $48,775,723 | |
| 2025 | $49,475,723 | |
| 2026 est. | $289,467 |
FAQ
Who is eligible to apply?
For-profit small businesses with 500 or fewer employees. Your company must plan to conduct substantial research or development work.
What's the difference between Phase I and Phase II?
Phase I (R43) is proof-of-concept funding, typically shorter and smaller. Phase II (R44) is for companies that have completed Phase I or show advanced progress.
Are clinical trials required?
No. Clinical trials are optional components. Include them only if relevant to your innovation and research plan.
How competitive is this program?
Very competitive. Success rates are typically 10-15% for SBIR programs. Strong preliminary data and clear commercialization plans improve your chances.
What is the funding range?
Phase I awards typically range $150,000-$250,000. Phase II awards typically range $800,000-$1,500,000. Exact amounts vary by program area.
💡 Tips for applicants
- Demonstrate clear commercialization potential and market need. Reviewers want to fund innovations with real-world impact and business viability.
- Provide strong preliminary data or proof-of-concept results. This is critical for Phase II applications and highly competitive Phase I submissions.
- Include a detailed, realistic budget and timeline. Show you understand the technical and financial requirements of your project.
- Clearly explain how federal funding reduces business risk. Show why your company cannot complete this innovation without SBIR support.
- Address scientific and technical merit equally with commercial potential. Balance cutting-edge research with practical feasibility and business strategy.
⚠️ Common mistakes
Applicants focus only on scientific merit and ignore commercialization potential. SBIR reviewers evaluate both innovation and business viability equally.
Budget narratives lack sufficient detail or realism. Show month-by-month spending, justify all costs, and explain how funds accelerate product development.
Proposals underestimate competition or fail to demonstrate Phase I-to-Phase II transition plans. Be explicit about milestones and de-risking strategies.
Similar grants
- OPEN NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional) — National Institutes of Health
- OPEN NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) — National Institutes of Health
- OPEN Small Business Transition Grant for New Entrepreneurs (Parent R43/R44 Clinical Trial Optional) — National Institutes of Health
- OPEN Small Business Transition Grant for New Entrepreneurs (Parent R41/R42 Clinical Trial Optional) — National Institutes of Health
- CLOSED Forecast to Publish a Notice of Funding Opportunity for SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional — National Institutes of Health