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National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program – Fiscal Year 2027

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75N91026R00109Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The National Cancer Institute is issuing a presolicitation for its SBIR Innovative Concept Award Program targeting small businesses to advance highly innovative technologies for pediatric and rare cancers, defined as malignancies with a U.S. prevalence under 200,000 individuals and a five-year survival rate below 50 percent. Proposals must focus on therapeutic or preventative technologies or on devices, diagnostics, and digital health tools, with a strong scientific premise supported by literature or preliminary internal research, though no preliminary data is required. Each proposal must clearly identify the clinical problem, target cancer type, and outline a defined development path with experiments designed to generate de-risking and proof-of-concept data. Successful applicants will also be expected to develop or refine a business model and commercialization plan, strengthening their entrepreneurial readiness. This is a total small business set-aside, restricted to firms with no more than 500 employees including affiliates, and the NAICS code 54171 applies. Submission of white papers is no longer permitted under this solicitation. The formal solicitation is anticipated to be released on or around July 17, 2026, with proposals due in late September, and an optional interim review window in June for feedback on scope alignment. All other terms and conditions remain unchanged from prior iterations.

General Info

Small businesses under 500 employees can bid to develop innovative therapies, diagnostics, or prevention tools for pediatric and rare cancers with low survival rates.

Agency

Department Of Health And Human Services → NIH NciView Agency

NAICS

Place of Performance

MD, USA

Set-Aside

SBA

Documents

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No documents available

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Timeline

1 update
PhasePresolicitation
Posted

Presolicitation

Amendment 1

Contract was updated

Response Deadline

Submission deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → NIH Nci
Contacts1 person available
OfficeBethesda, MD, 20892, USA
Organization / Agency
Department Of Health And Human Services → NIH Nci
View Agency Profile
Office AddressBethesda, MD, 20892, USA
Contacts
Kathleen Sears

Full Description

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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.

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