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

This document is Amendment 0002 to Request for Proposals (RFP) #75N98026R00109, issued by the National Institutes of Health (NIH) Office of Acquisitions and Logistics Management (OALM) on behalf of the National Cancer Institute (NCI). The amendment specifically modifies the solicitation for the "National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Phase I Award Program." The primary purpose of this amendment is to remove the Data Management Sharing Plan requirement. Consequently, all references to this plan are deleted from the solicitation, including Section 5.9 (Management and Sharing of Research Data), Section 6.1 (Evaluation Process, Evaluation of Data Management and Sharing Plan), and Section 8.5 (Technical Proposal Content (I) Scientific Data Sharing). The deadline for the receipt of proposals remains unchanged and is set for September 21, 2026, at 5:00 PM. All other terms and conditions of the original solicitation remain in full force and effect. Potential offerors must acknowledge receipt of this amendment prior to the specified deadline to avoid potential rejection of their proposals.

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.

Amendment 0003 to Solicitation Number 75N98026R00109, issued by the National Cancer Institute (NCI) Office of Acquisitions, provides clarification and answers to written questions regarding the FY2027 NCI Small Business Innovation Research (SBIR) Innovative Concept Phase I Award Program. Key clarifications provided in this amendment include: - **Proposal Deadline**: The submission deadline remains unchanged at 5:00 PM Eastern Time on September 21, 2026. - **No White Papers**: Contrary to information on the program website, NCI confirms that white papers are not requested or accepted for this solicitation cycle, and no reviews of white paper submissions will occur. - **Required Documentation**: Offerors must submit a signed copy of page 1 of the SF30 Amendment document alongside their Business Proposal. - **Scope Alignment**: The program supports innovative technologies for the prevention, diagnosis, detection, and treatment of pediatric and/or rare cancers. Technologies primarily focused on supportive care, survivorship, treatment-related complications, or research-only tools are deemed out of scope. - **Project Structure**: Phase I proposals must be scoped for a 12-month, $300,000 project period and focus on generating de-risking proof-of-concept data. Benchtop and in vitro feasibility studies are permitted, but non-exempt human subjects research is strictly prohibited. - **Administrative Details**: Biosketches should utilize the MS Word template provided in the solicitation. Character limits specified within the technical proposal template include spaces. G&A/Indirect Cost rates under 40% do not require formal negotiation with the NIH.