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

THIS EDIT IS TO POST AMENDMENT #3. AMENDMENT #3 IS TO provide key questions and answers received in writing by email. Offerors are required to submit a signed copy of the SF30 Amendment (page 1 only) with their Business Proposal submission.

The deadline for receipt of proposals remains unchanged at 5:00pm, September 21, 2026. All other terms and conditions of the solicitation remain unchanged. PLEASE SEE ATTACHED AMENDMENT #3 PDF. _______________________________________________________________________________________________________ THIS EDIT IS TO POST AMENDMENT #2.

AMENDMENT #2 IS TO remove the Data Management Sharing Plan requirement and all references under Sections 5.9 Management and Sharing of Research Data, 6.1 Evaluation Process, Evaluation of Data Management and Sharing Plan, 8.5 Technical Proposal Content (I) Scientific Data Sharing. The deadline for receipt of proposals remains unchanged at 5:00pm, September 21, 2026. All other terms and conditions of the solicitation remain unchanged.

PLEASE SEE ATTACHED AMENDMENT #2 PDF. ________________________________________________________________________________________________________ ORIGINAL SOLICITATION DESCRIPTION: The National Cancer Institute (NCI) invites small business concerns to submit research proposals under this Phase I Small Business Innovation Research (SBIR) contract solicitation. Firms with the capability to conduct research and development (R&D) in the health-related topic areas referred to below and described more fully in Section 11.0, and to commercialize the results of that R&D, are encouraged to participate. The topic areas that are being sought under this solicitation are: Topic 1: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers.

For this solicitation rare cancers with a 5-year survival rate of less than 50% are encouraged.

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. The National Cancer Institute is soliciting proposals from small business concerns who are looking for an opportunity to perform a few key activities to demonstrate proof-of-concept and feasibility of untested but potentially transformative, game-changing research and development (R&D) technologies to help cancer patients, providers and caregivers, in conjunction with Small Business Innovation Research (SBIR) program objectives.

The NCI has established a high-risk, high-reward SBIR Innovative Concept Award Program for this purpose. Preliminary data is not required; however, the ideas should have sound scientific premise either based on the offeror's own research or literature evidence. Proposals will need to identify an anticipated product that will be developed and clearly lay out the anticipated development path.

Proposals will need to clearly identify the clinical problem and cancer type(s) that the proposal will focus on with adequate justification. In addition, the offerors should propose experiments to obtain initial de-risking and proof-of-concept data.

Note: Non-exempt Human subjects research will not be supported under this solicitation. Phase I Concept Award contractors will be informed of the opportunity to apply for Phase II. Only one Phase II award may result from a single Phase I SBIR contract.

The United States Department of Health and Human Services (HHS) is not obligated to make any awards under this solicitation. All awards are subject to the availability of funds. HHS is not responsible for any monies expended by the offeror before award of any contract.