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

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75N98026R00109Federal

Contract Overview

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

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The National Cancer Institute (NCI) is soliciting research proposals from small business concerns for the Small Business Innovation Research (SBIR) Innovative Concept Phase I Award Program under solicitation 75N98026R00109. This high-risk, high-reward program focuses on the development of therapeutic, preventative technologies, devices, diagnostic tools, or digital health tools specifically for pediatric and rare cancers, with a preference for rare cancers having a five-year survival rate of less than 50 percent. The goal is to demonstrate proof-of-concept and feasibility for transformative technologies to derisk them for future Phase I or Phase II awards. While preliminary data is not required, proposals must be based on a sound scientific premise and clearly identify the clinical problem and the anticipated development path. Non-exempt human subjects research is not supported. The program provides a base R&D budget of up to 300,000 dollars for up to 12 months, with an additional 6,500 dollars available for Technical and Business Assistance. Proposals are evaluated on a competitive basis using a triage process and weighted factors, including potential for innovation and impact (50 percent), scientific rationale and approach (20 percent), commercialization potential (20 percent), and personnel and resources (10 percent). Applicants must be registered in the System for Award Management and the SBA Company Registry. Proposals must be submitted via the electronic Contract Proposal Submission portal by 5:00pm on September 21, 2026. Recent amendments have provided a technical proposal form, removed the Data Management Sharing Plan requirement, and provided clarified questions and answers. Offerors are required to submit a signed copy of Amendment 3 with their business proposal.

General Info

Small businesses advance novel therapies or diagnostics for pediatric and rare cancers with low survival rates through Phase I SBIR funding.

Agency

Department Of Health And Human Services → NIH NciView Agency

NAICS

54171

Place of Performance

MD, USA

Set-Aside

SBA

Documents

(5)

Amendment 0001 to RFP 75N98026R00109 for NCI SBIR Innovative Concept Phase I Award Program

PDFamendment

NCI SBIR Innovative Concept Phase I Solicitation 75N98026R00109

PDFrfp

Amendment 0003 to Solicitation 75N98026R00109 SBIR Phase I Innovative Concept Award

PDFamendment

NCI SBIR FY25 Phase I Concept Award Technical Proposal Form

PDFtechnical-proposal-form

Amendment 0002 to RFP 75N98026R00109 for NCI SBIR Innovative Concept Phase I Award Program

PDFamendment

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Timeline

3 updates
PhaseSolicitation
Posted

Solicitation

Amendment 1

Contract was updated

Amendment 2

Contract was updated

Amendment 3

Contract was updated

Response Deadline

Submission deadline

Response 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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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.

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