National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program – Fiscal Year 2027
Closed Pre-Solicitation Posted
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- Solicitation number
- 75N91026R00109
- Agency
-
National Cancer Institute
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- Place of performance
- United States
- Points of contact
-
- Kathleen Sears ncioasbir@mail.nih.gov
Notice details come from SAM.gov. Updated .
About this opportunity
The National Cancer Institute is soliciting proposals from small businesses to demonstrate technical feasibility and proof-of-concept for innovative technologies addressing pediatric cancers and rare cancers, with proposal submissions due July 17, 2026. This solicitation is set aside for total small business.
Two topic areas are open. Topic 1 focuses on therapeutic or preventative technologies for treatment or prevention of pediatric cancers and rare cancers. Topic 2 addresses devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of pediatric cancers and rare cancers. Rare cancers with a 5-year survival rate below 50% are encouraged; the program defines rare cancer as a malignancy with fewer than 200,000 individuals in the U.S., consistent with the FDA Orphan Drug Act.
Proposals must identify an anticipated product and development path and must clearly establish the clinical problem and cancer type(s) with adequate justification. Preliminary data is not required; however, sound scientific premise is mandatory, supported either by the offeror's own research or literature evidence. Offerors should propose experiments to obtain initial de-risking and proof-of-concept data. Prevalence estimates must be supported by authoritative sources such as the NCI Surveillance, Epidemiology, and End Results Program (SEER) database or, where direct estimates are unavailable, scientifically justified epidemiologic approximations based on published literature.
Amendment 0001 clarified that white paper submissions are no longer requested and will not be accepted. This is an SBIR Innovative Concept Award Program for Fiscal Year 2027.
Notice text
2 versions
Update #2 · Latest ·
AMENDMENT 0001: 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.
Description
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/
Attachments/Links: No attachments or links have been added to this opportunity.
Update #1 ·
Description
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/
Attachments/Links: No attachments or links have been added to this opportunity.
Notice history
| Notice | Type | Posted |
|---|---|---|
| National cancer institute (NCI) small business innovation research (SBIR) innovative concept phase I award program | Solicitation | |
| This notice | Pre-Solicitation |
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