NATIONAL CANCER INSTITUTE (NCI) SMALL BUSINESS INNOVATION RESEARCH (SBIR) INNOVATIVE CONCEPT PHASE I AWARD PROGRAM

This document is a Technical Proposal Submission Checklist and template packet for the Department of Health and Human Services (HHS) Small Business Innovation Research (SBIR) Phase I Concept Award, specifically tailored for innovative technologies addressing rare or pediatric cancers. It outlines the mandatory structure and submission requirements for small businesses seeking federal contract funding. Key components of the application packet include: - **Proposal Cover Sheet & Certifications:** Collects administrative details, business size/type certifications, and disclosures regarding human subjects or vertebrate animals. - **Abstract of Research Plan:** A public, 200-word summary detailing the project's long-term objectives, health relevancy, and potential for technological innovation. - **Technical Proposal Content:** Structured sections with strict character limits (generally 4,500 characters) covering the clinical problem, proposed technological solution, disruptive innovation, experimental approach/methodology, product development strategy, commercial path, and resources. - **Statement of Work (SOW):** A formal, multi-page template defining the project scope, technical objectives with quantitative milestones, a 12-month development timeline, and compliance with the National Institutes of Health (NIH) Data Management and Sharing Policy. - **I-Corps™ Program Agreement:** A mandatory commitment for the contractor's three-member team to participate in the NIH entrepreneurial training program, which includes customer discovery workshops and weekly faculty meetings. This template ensures applicants provide standardized, scientifically rigorous, and commercially viable proposals aligned with NIH and National Cancer Institute (NCI) guidelines.

Amendment 0001 has been issued for Request for Proposal (RFP) #75N98026R00109, titled "National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Phase I Award Program." Issued on July 10, 2026, by the National Institutes of Health (NIH) Office of Acquisitions and Logistics Management (OALM), the sole purpose of this amendment is to officially provide "Attachment 1 – Technical Proposal Form." All other terms, conditions, and the original proposal submission deadline of 5:00 p.m. on September 21, 2026, remain unchanged. Potential offerors must acknowledge receipt of this amendment prior to the designated deadline to prevent the rejection of their offers.

The National Cancer Institute (NCI) has issued Solicitation No. 75N98026R00109 for the Small Business Innovation Research (SBIR) Innovative Concept Phase I Award Program. Closing on September 21, 2026, this high-risk, high-reward program offers up to $300,000 in funding to support untested, potentially transformative research and development (R&D) aimed at pediatric and rare cancers. Preliminary data is not required, but proposals must establish a sound scientific premise, target clinical needs, and outline a clear development path. The solicitation features two primary topic areas: Topic 1 focuses on therapeutic or preventative technologies, and Topic 2 covers devices, diagnostics, and digital health tools. Non-exempt human subjects research is excluded from funding. Eligible applicants must qualify as Small Business Concerns (SBCs) under SBA guidelines, perform at least two-thirds of the research within the United States, and ensure the primary investigator is employed by the SBC. HHS limits submissions to nine applications per SBC per fiscal year. In addition to standard registration requirements in the System for Award Management (SAM) and the SBA Company Registry, this solicitation introduces a new requirement (Appendix J) mandating disclosures of foreign affiliations and relationships. Proposals must be submitted electronically through the eCPS portal, and questions are due by August 1, 2026. Successful Phase I contractors will subsequently have the opportunity to apply for Phase II awards.