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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 Phase I Small Business Innovation Research (SBIR) proposals under the Innovative Concept Award Program focused on advancing transformative research and development for pediatric cancers and rare cancers with a five-year survival rate below 50%. This Total Small Business Set-Aside, identified by solicitation number 75N98026R00109 and NAICS code 54171, is open to small business concerns that can demonstrate the scientific feasibility and commercial potential of untested technologies aimed at therapeutic, preventative, diagnostic, or digital health applications. Proposals must clearly define the clinical problem, specify the targeted cancer type, and outline a development path toward a tangible product, supported by a sound scientific premise derived from literature or preliminary internal research—though preliminary data is not required. Two primary topic areas are prioritized: development of novel therapeutics or preventative strategies for pediatric and rare cancers, and creation of devices, diagnostic tools, or digital health solutions for detection and treatment. Notably, non-exempt human subjects research is strictly prohibited, and all proposals must comply with the required electronic submission format via eCPS, including a single PDF technical proposal incorporating the mandatory ATTACHMENT 1 form, NIH biosketches, and letters of support, along with a separate business proposal and the always-required Human Subjects and Clinical Trials Information Form, even if no human research is involved. The solicitation outlines a $300,000 base R&D budget with an optional additional $6,500 for technical and business assistance, for a total potential contract value of $306,500, all payable via electronic funds transfer upon successful completion and government acceptance of deliverables. Offers must be registered in the System for Award Management (SAM) with the correct purpose designation and hold an active Unique Entity Identifier, and must also be registered in the SBA Company Registry, submitting proof as part of the business proposal. Proposals are evaluated through a two-stage process: first, a peer review panel determines technical acceptability based on equal-weighted criteria including scientific rationale, approach, and alignment with the clinical need, and second, NCI program staff assess feasibility and programmatic alignment. Failure to meet either the technical acceptability threshold or a security risk determination results in disqualification. Contractors are subject to government inspection, must submit periodic technical progress reports tied to payment milestones, and are required to comply with all federal regulations including Section 508 accessibility standards, E-

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

54171View NAICS

Place of Performance

MD, USA

Set-Aside

SBA

Documents

(3)

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

PDF•amendment

NCI SBIR Innovative Concept Phase I Solicitation 75N98026R00109

PDF•rfp

NCI SBIR FY25 Phase I Concept Award Technical Proposal Form

PDF•technical-proposal-form

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Timeline

1 update
PhaseSolicitation
Posted

Solicitation

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
contact@example.gov

Full Description

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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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8 days ago

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