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Fast track proposals will not be accepted. Direct-to-Phase II proposals will not be accepted.Non-exempt Human subjects research are not allowed. Budget (total costs, per award): Up to $300,000 for up to 12 months with an additional $6,500 for TABA if requested. About 9,550 children in the United States under the age of 15 will be diagnosed with cancer in 2025 (https://www.cancer.org/cancer/cancer-in-children/key-statistics.html). Cancer is the leading cause of death from disease in children ages 1 to 14 in the US after infancy. Similarly, as a group, rare cancers are the leading cause of cancer deaths in the United States (https://rarecancer.org/). For this solicitation, rare cancers include all the cancers listed by the NIH Genetics and Rare Diseases Information Center. The list can be found here: (https://rarediseases.info.nih.gov/search-result?category=Cancer). Access the NCI Surveillance, Epidemiology, and End Results Program (SEER) database (https://seer.cancer.gov/) for more information regarding 5-year cancer survival rates. Because of smaller patient populations and challenging development pathways, development of new technologies focused on pediatric and rare cancers lag significantly compared to other major cancers. Innovative and transformative solutions focused on prevention, diagnosis, detection, and treatment in both pediatric cancers and rare cancers are urgently needed. Rather than just the tried and tested approaches that have not led to much success and progress, bold and “out of the box” ideas that are still based on sound scientific premise are needed to make a significant impact in the prevention, diagnosis, treatment, and care of patients with pediatric and/or rare cancer. Thus, the NCI SBIR Development Center has developed the NCI SBIR Innovative Concept Award program to encourage the development of high-risk innovative and disruptive technologies. The Concept Award program will provide funding to small businesses to explore the technical feasibility and demonstrate proof of concept for the development of highly innovative therapies, devices, diagnostic tools, or preventive strategies focused on pediatric and rare cancers. The focus is on innovation and “out of the box” ideas that have not been tried and tested before. So, preliminary data is not required; however, proposed ideas should have sound scientific premise either based on the offeror’s own research or referenced literature evidence. Offerors are eligible to apply if they have disruptive ideas based on sound scientific premise with a potential to make an impact in these cancers. The goal of the funding is for offerors to generate de-risking technical data that provides key proof of concept validation. We also want the offerors to explore the commercial potential and development path of the technology during the award period. In addition to funding, the program will also provide additional business and commercialization resources including entrepreneurship training to explore and refine the business model and commercialization plan. Therapeutic Projects: The offeror could propose most or all of these activities for pediatric or rare cancers. • Target validation • Optimized drug candidate screening • Identification of lead and lead candidate optimization • In vivo efficacy studies • Preliminary PK/PD studies