Innovative Concept Award Program for Small Business Research in Cancer

The purpose of this amendment is to clarify submission

requirements. White Paper submissions are no longer being requested and will not be accepted under any resultant solicitation. All other terms and conditions remain unchanged. The National Cancer Institute (NCI) is soliciting proposals from small business concerns to perform key activities to demonstrate technical feasibility and proof-of-concept for the development of highly innovative and potentially transformative technologies in the following areas: Topic 1: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers. Topic 2: Development of devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of Pediatric Cancers and/or Rare Cancers. For this solicitation, rare cancers with a 5-year survival rate of less than 50% are encouraged, and rare cancers include all the cancers listed by the NIH Genetics and Rare Diseases Information Center. For the purposes of this solicitation, a rare cancer is defined in accordance with the U.S. Food and Drug Administration (FDA) Orphan Drug Act as a malignancy with a total U.S. prevalence of fewer than 200,000 individuals. Prevalence estimates should be supported by authoritative data sources (e.g., SEER) or where direct estimates are not available, by scientifically justified epidemiologic approximations based on published literature. For more information regarding 5-year cancer survival rates, see the NCI Surveillance, Epidemiology, and End Results Program (SEER) database at: https://seer.cancer.gov/ Preliminary data is not required. However, the proposal must have a sound scientific premise, either based on the offeror's own research or literature evidence. Proposals shall both identify an anticipated product to be developed and clearly lay out the anticipated development path. Proposals must clearly identify the clinical problem and cancer type(s), along with adequate justification. In addition, offerors should propose experiments to obtain initial de-risking and proof-of-concept data. Awards will also include

requirements to enhance entrepreneurial skills, to develop or refine a business model, and a commercialization plan. This Concept Award solicitation is intended to serve as a pipeline for the federal Small Business Innovation Research (SBIR) program. This is a total small business set-aside solicitation, and only proposals from eligible small businesses will be considered for award. This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. To be eligible as a small business, the offeror may have no more than 500 employees, including the employees of its affiliates (see 13 C.F.R. § 121.702). For other

requirements, see the SBA's SBIR/STTR Policy Directive: https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf The solicitation for the NCI SBIR Innovative Concept Award Program is anticipated to be made available on or around July 17, 2026. This solicitation is expected to have a closing date in late September for receipt of proposals, with an interim deadline in June for submission and consideration of water papers. which will allow time for the NCI to provide feedback on whether the proposed idea falls within the scope of what this solicitation is seeking. Note – SBIR / STTR Grant Opportunities Other SBIR and STTR contract and grant opportunities are also available. Companies are encouraged to visit: https://seed.nih.gov/small-business-funding/find-funding For general information regarding the NCI SBIR Program, please refer to: https://sbir.cancer.gov/ : No

attachments or links have been added to this opportunity. Kathleen Sears Contracting . 11A35P Bethesda, MD 20892 USA to this opportunity.