SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)

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Description

This opportunity from the National Institutes of Health (NIH) is designed to help U.S. small businesses bridge the gap between SBIR/STTR Phase II/IIB research and successful commercialization. The program provides funding for technical assistance and late-stage research and development (R&D) activities that are not typically supported by standard Phase II or IIB grants or contracts. The goal is to facilitate the transition of promising biomedical technologies, devices, or products toward the marketplace.

Eligible activities include, but are not limited to, regulatory strategy development, manufacturing scale-up, independent replication of key studies, IND-enabling studies, and other technical or business assistance. A significant portion of the work may be subcontracted, but the small business must retain oversight and management responsibility.

Clinical trials are not permitted under this funding opportunity.

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Due Dates

• Letter of Intent (optional): 30 days prior to the application due date
• Application Deadline: September 5, 2025 (5:00 PM local time of applicant organization)
• Expiration Date: September 6, 2025

Applicants are encouraged to apply early to allow time for corrections.

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Funding Amount

• Maximum budget: Up to $4,091,634 total costs for the entire project period (direct + indirect + fee), unless a lower cap is set by the relevant NIH Institute/Center.
• Project period: Up to 3 years (some Institutes/Centers may limit to 1–2 years).
• Institute/Center-specific caps: Many NIH Institutes/Centers set lower maximum budgets (e.g., NIAID: $1M/year up to 3 years; NCI: $250,000 total; NIDCD: $1.75M/year; NINDS: $300,000 total; see full list).

Applicants are strongly encouraged to contact the relevant NIH program officer to confirm budget limits and eligibility.

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Eligibility

• Applicant type: U.S. small business concerns (SBCs) only.
• Prior award required: Must have an active or recently completed (within 36 months) NIH SBIR or STTR Phase II or Phase IIB grant, contract, or cooperative agreement.
• Foreign entities: Non-U.S. organizations are not eligible; foreign components may be allowed if well justified.
• Other requirements:
  • SBC must be organized for profit, have a U.S. place of business, and meet SBA size standards.
  • Only one CRP award per project is allowed.
  • The SBC must perform a substantive role in the project and cannot serve merely as a conduit for funds.
  • Clinical trials are not allowed under this NOFO.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required registrations: SAM, SBA Company Registry, eRA Commons, and Grants.gov.
• Application guide: Follow the SBIR/STTR (B) Application Guide and the specific instructions in the NOFO.
• Letter of Intent: Optional but recommended; submit to the relevant NIH Institute/Center contact.
• Key application components:
  • Project summary/abstract
  • Specific aims (for technical assistance, state intended accomplishments)
  • Research strategy (significance, innovation, approach)
  • Commercialization plan (including statement of need, commercialization history, management plan, regulatory plan, fundraising plan)
  • Progress report on prior SBIR/STTR work
  • Letters of support (including from third-party investors, if applicable)
  • Budget and justification (note: patent/FDA filing fees are not allowed)
• Review: Applications are peer reviewed for scientific and technical merit, commercialization potential, and alignment with NIH priorities.

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Additional Information

• Outsourcing: A significant portion of the work may be subcontracted, but the SBC must maintain oversight and management.
• No cost sharing required.
• No separate Technical and Business Assistance (TABA) funding may be requested.
• Data management: All applicants must address data management and sharing, but SBIR/STTR recipients may retain data rights for up to 20 years.
• Reporting: Annual progress and financial reports are required.

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External Links

• NIH Funding Opportunity Announcement (PAR-23-219)
• Grants.gov Opportunity Listing
• NIH SBIR/STTR Program Overview
• NIH List of Institutes and Centers
• How to Apply - Application Guide

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Contact Information

Institute/Center-specific scientific contacts:

• Full list of contacts by NIH Institute/Center
  (Examples: NIA – niasmallbusiness@mail.nih.gov; NCI – monique.pond@nih.gov; NIAID – natalia.kruchinin@nih.gov; see link for all.)

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