NIH SBIR/STTR Omnibus Solicitation

Why this cornerstone funding source was missing

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are the lifeblood of early-stage biomedical innovation. NIH’s Omnibus Solicitation is the flagship mechanism that disburses more than $1.3 billion annually across Phase I and Phase II awards, yet it was missing from FindMyMoney. Without it, biotech founders, medtech engineers, and translational researchers lacked guidance on a program that routinely launches companies toward FDA clearance and venture investment. Adding an in-depth entry demystifies eligibility, application strategy, and commercialization planning for one of the most popular, competitive funding streams in the health innovation ecosystem.

Program overview

• Purpose: Fund proof-of-concept and prototype development for diagnostics, therapeutics, devices, digital health tools, research instrumentation, and healthcare IT.
• Agencies: All 24 NIH Institutes and Centers (ICs), plus the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Administration for Community Living (ACL) participate.
• Funding structure: Phase I supports feasibility and early development (typically 6–12 months). Phase II supports full R&D toward commercialization (up to 2 years). Fast-Track and Direct-to-Phase II options exist for projects with strong preliminary data.
• Review: Applications undergo scientific peer review and programmatic review. Scores consider significance, investigators, innovation, approach, environment, and commercialization potential.

Eligibility details

• Small business size: Must be organized for profit, U.S.-owned (≥51% by individuals who are U.S. citizens or permanent residents, or by single U.S. business), and have ≤500 employees including affiliates.
• Principal Investigator (PI): For SBIR, PI must be employed ≥51% by the small business at the time of award. For STTR, PI can be primarily employed by the small business or the partnering research institution, but at least 10% effort must come from each.
• STTR collaboration: Requires a formal partnership with a nonprofit research institution (university, federal lab). At least 40% of work must be performed by the small business and 30% by the research institution.
• Human subjects/animal use: Projects involving clinical trials or vertebrate animals require additional protections, IRB/IACUC approvals, and compliance with Good Clinical Practice.

Crafting a competitive application

1. Align with institute priorities

Study Institute and Center (IC) interests. Contact NIH program officers early to confirm fit. Many ICs publish topic areas or special announcements. Tailor your Specific Aims to address unmet medical needs aligned with an IC’s mission (e.g., NCI for oncology diagnostics, NIA for Alzheimer’s devices).

2. Build a compelling Specific Aims page

The Specific Aims document is your elevator pitch. Clearly state the unmet need, your solution, objectives for Phase I/II, and quantifiable milestones. Emphasize innovation and commercial potential. Include go/no-go criteria to demonstrate disciplined development.

3. Assemble a multidisciplinary team

Highlight technical expertise (principal investigator, engineers, clinicians), commercialization leadership (CEO, business development), and regulatory advisors. Include letters of support from clinical collaborators, key opinion leaders, and prospective customers. For STTR, describe the collaboration plan, IP agreements, and communication cadence between the company and research institution.

4. Present rigorous technical approach

Outline experiments, prototypes, validation studies, and statistical analyses. Include timelines with milestones, risk mitigation strategies, and quality control plans. If proposing a clinical trial, provide study design, inclusion/exclusion criteria, endpoints, and data management procedures.

5. Develop a commercialization plan

Even in Phase I, articulate market opportunity, competitive landscape, regulatory pathway (FDA classification, required submissions), reimbursement strategy, and intellectual property (patents, trade secrets). For Phase II, submit a full Commercialization Plan covering market segmentation, sales strategy, manufacturing scale-up, and five-year financial projections.

6. Budget accurately

Use NIH budget forms (SF424 R&R). Include direct costs (personnel, consultants, equipment, supplies, travel, subawards) and indirect costs (limited to 40% of total direct costs without negotiated rate). Request budget waivers if your project requires more than standard caps (e.g., costly animal studies, clinical trials, complex device manufacturing) and justify with documented need.

7. Address review criteria thoroughly

• Significance: Demonstrate the health burden and market demand. Cite epidemiology, cost-of-care data, or health system gaps.
• Investigator(s): Showcase team qualifications, prior SBIR/STTR experience, publications, patents.
• Innovation: Explain how your technology differs from current solutions and solves bottlenecks.
• Approach: Provide detailed methodology, feasibility data, and contingency plans.
• Environment: Describe facilities, incubators, manufacturing partners, and institutional support.
• Commercialization: Highlight letters from investors, strategic partners, or customer discovery interviews confirming interest.

Application process timeline

1. 2–3 months before deadline: Register for SAM.gov, Grants.gov, eRA Commons, and SBA Company Registry. Assign PI accounts and confirm institutional profiles.
2. 6–8 weeks: Draft Specific Aims and discuss with NIH program officer. Refine based on feedback.
3. 4–6 weeks: Complete Research Strategy, Commercialization sections, budget, biosketches (new NIH format), and facilities descriptions. Collect letters of support.
4. 2–3 weeks: Finalize human subjects/animal sections, data management plan, resource sharing. Validate attachments (PDF format, page limits).
5. Submission: Upload via Grants.gov/eRA Commons before 5 p.m. local time on deadline day. Watch for errors and submit corrections within the two-day window.
6. Post-submission: Respond to Just-In-Time (JIT) requests for updated info (IRB approval, other support). Prepare to pitch during due diligence calls if selected.

Post-award execution tips

• Project management: Use milestone tracking to monitor progress. Document achievements to support Phase II or Fast-Track transitions.
• Financial controls: Maintain compliant accounting systems, track allowable costs, and submit Federal Financial Reports (FFRs) and Research Performance Progress Reports (RPPRs) on time.
• Intellectual property: File patents before public disclosures, negotiate licensing with research institutions (for STTR), and consider SBIR data rights protections.
• Regulatory strategy: Engage FDA through pre-submission meetings, IND/IDE filings, or Breakthrough Device designations. Budget for quality systems (ISO 13485, GMP) as you approach commercialization.
• Follow-on funding: Leverage Phase II to pursue Phase IIB bridge awards (up to $3.4 million), NIH Catalyze loans, BARDA partnerships, or venture investment. Document matching funds to demonstrate scalability.

Advanced strategies

Pursue Fast-Track or Direct-to-Phase II

If you have strong preliminary data, submit a Fast-Track (combined Phase I/II) or Direct-to-Phase II application to accelerate timelines. Provide robust feasibility data to justify skipping Phase I review.

Utilize Technical and Business Assistance (TABA)

Request up to $50,000 (Phase II) for commercialization support—market research, regulatory consulting, manufacturing readiness. Select reputable vendors and tie activities to commercialization milestones.

Build non-dilutive funding stacks

Combine SBIR/STTR with state matching programs (e.g., Phase 0 grants, angel tax credits), DoD SBIRs, NSF SBIRs, or DOE SBIRs to de-risk development before equity financing.

Strengthen customer discovery

Participate in I-Corps or NIH Innovation Corps to validate value propositions. Include customer discovery results in your application to show market traction.

Plan exit pathways

Outline acquisition targets, licensing strategies, or go-to-market partnerships with strategics (pharma, medtech, health systems). Demonstrate how NIH funding bridges you to scale.

Success scenario

A Boston-based digital therapeutics startup wins a Phase I SBIR from NIMH to develop an AI-guided CBT platform for adolescents with anxiety:

• Uses funding to validate machine learning algorithms, run feasibility trials with 60 patients, and refine UX with clinician input.
• Submits a successful Phase II fast-track with randomized controlled trial design, FDA SaMD regulatory plan, and commercialization roadmap partnering with school districts.
• Leverages TABA to hire reimbursement consultants and apply for CPT codes.
• Secures $8 million in venture capital post-Phase II review, accelerated by strong NIH endorsements and clinical data. By capturing NIH SBIR/STTR support, the startup advances from concept to commercialization while retaining equity and building a robust regulatory and reimbursement strategy.

Including the NIH SBIR/STTR Omnibus in FindMyMoney provides health innovators with the tactical insights required to secure the nation’s most reliable source of non-dilutive biotech funding.